510(k) · Cleared
ClearedMRI Compatibility for Existing Straumann Dental Implant Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Jun 17, 2019 after a 94-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jun 17, 2019
- Review
- 94 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK190662 MRI Compatibility for Existing Straumann Dental Implant SystemsStraumann USA, LLC · 2019
- Descendant · cites it directly · 1 of its ownK192893 Straumann Ceramic Healing AbutmentsInstitut Straumann AG · 2020
- Descendant · 2 generations on · 0 of its ownK232383 iPhysio® SystemEuroteknika · 2025
- Descendant · cites it directly · 0 of its ownK201681 Straumann Immediate Temporary AbutmentsInstitut Straumann AG · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K190662 | MRI Compatibility for Existing Straumann Dental Implant Systems | Straumann USA, LLC | 2019 | — |
| +1 | K192893 | Straumann Ceramic Healing Abutments | Institut Straumann AG | 2020 | — |
| +2 | K232383 | iPhysio® System | Euroteknika | 2025 | — |
| +1 | K201681 | Straumann Immediate Temporary Abutments | Institut Straumann AG | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K192893 (Institut Straumann AG, 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
Modification to ITI DENTAL IMPLANT SYSTEM ITI self-tapping implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. ITI DENTAL IMPLANT SYSTEM ITI solid screw implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or…
Read the full statement (6,445 words)
Modification to ITI DENTAL IMPLANT SYSTEM
ITI self-tapping implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
ITI DENTAL IMPLANT SYSTEM
ITI solid screw implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
ITI DENTAL IMPLANT SYSTEM
The ITI anterior implant is intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the anterior implant is indicated for replacement of single lateral incisors in maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited (minimum 5 mm) and where vestibulo-oral bone is restricted (minumum 5 mm). The anterior implant can also be used as a support for a full arch implant-borne restoration, but only in conjunction with a standard ITI 4.1mm dental implant.
ITI DENTAL IMPLANT SYSTEM
ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
The abutment is placed in the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The titanium temporary posts are screwed into the dental implants and serve as a base for a temporary prosthetic restoration. The plastic burn-out copings provide a cast inner surface for mating with the abutment and implant and are for use in casting restorations directly from porcelain-fused-to-metal alloy without the use of machined metal components. The healing cap and closure screw are titanium devices which are mounted onto the dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the inner configuration of the implant. The healing cap also protects the outer 45 degree shoulder of the implant during the healing phase and helps stabilize and maintain the soft tissue.
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
The ITI synOcta angled abutments for Wide Neck Implants are indicated for use in cases where the placement of an implant requires an angled reconstruction for an optimal result. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
Abutments are intended to be placed in the dental implant to provide support for a prosthetic restorations such as crowns or bridges. The ITI esthetic are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
The abutment is placed in a dental implant to provide support for a prosthetic restoration such as a crown or bridge.
ITI DENTAL IMPLANT SYSTEM
ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
ITI DENTAL IMPLANT SYSTEM
ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The ITI Dental Implants are for single-stage or two-stage surgical procedures.
DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)
The device that is the subject of this submission is an angled titanium coping, which is a pre-manufactured component offering a pre-formed inner surface for mating with the dental implant abutment. The outer surface of the coping can be adapted to the individual restoration. The coping is angled and is used only with the ITI anterior implant.
ITI SYNOCTA MESO ABUTMENTS
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI provide synOcta Measo abutments and indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used in single tooth replacements and tooth restorations.
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
ITI implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. ITI Dental Implants are for single-stage or two-stage surgery.
ITI Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
Straumann Dental Implant System
The ITI Dental System implants are for single-stage or two-stage surgical procedures. The ITI Dental System implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases.
The Straumann Ortho implant system
The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or promedion area of the hard palate or in retromolor positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed ofter orthodontic treatment has been completed.
Ortho implants con be used in adults and juveniles (age 12 and older). In case of patients who have not yet completed skeletal growth (e.g. as shown by radiographic analysis of the hand/wrist), the ortho implant should be placed off the mid-line in the paramedian region of the palate in order to avoid the rnid-palatal suture.
Elliptic Matrix
The Elliptic Matrix is attached onto the Straumann Retentive Anchor abutment to provide support and retention for an overdenture.
Straumann Temporary Coping
The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration.
RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT
Abutments are intended to be placed into dental bridges to provide support for prosthetic reconstructions such as crowns or bridges.
RN SYNOCTA TEMPORARY MESO ABUTMENT
RN SynOcta Temporary Meso Abutments are for use in RN Straumann Dental Implants (04.8mm) for temporary restoration of single crowns in the anterior and posterior region for use up to six months.
STRAUMANN COMPUTER AIDED RESTORATION SERVICE
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Titanium Abutment is indicated for cemented restorations. The abutment can be used in single tooth replacements and multiple tooth restorations.
Straumann OrthoSytsem
The Straumann Palatal implant is intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for the attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
Palatal implants can be used in adults and juveniles age 12 and older. In case of patients who have not yet completed skeletal growth (e.g. as shown by radiographic analysis of the hand/wrist), the palatal implants should be placed off the mid-line in the paramedian region of the palate in order to avoid the mid-palatal suture.
Straumann Dental Implants
Straumann Regular Neck and Narrow Neck implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
The Straumann Regular Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients for single-stage or two-stage surgery.
The Straumann Narrow Neck implants are intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the Narrow Neck implant is indicated for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited (minimum 5 mm) and where vestibule-oral bone is restricted (minimum 5 mm). The Narrow Neck implant can also be used as a support for a full arch implant-born restoration, but only in conjunction with a standard Straumann 4.1 mm dental implant.
STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING
Copings are intended to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Ceramic Coping is indicated for cemented restorations. The coping can be used in single tooth replacements and multiple tooth restorations.
P.004 Implants
The P.004 Implants are intended for immediate, delayed or conventional placement in the maxilla and/or mandibular arches to support crowns bridges or overdentures in edentulous or partially edentulous patients.
They are intended for immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. Mesa abutments are indicated for cemented restorations particularly in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations.
WN SYNOCTA GOLD ABUTMENT
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.
P.004 RC TEMPORARY ABUTMENT P.004 TEMPORARY HEALING ABUTMENT (CAP)
P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months.
P.004 Healing Abutment, customizable (cap) is indicated for use in Straumann P.004 RC Bone Level implants to protect the inner configuration of the implant during the healing process. Maintains, stabilizes and forms the soft tissue and should be placed out of occlusion for up to six months.
STRAUMANN P.004 RC GOLD ABUTMENT
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
NARROW NECK TEMPORARY COPING
The Narrow Neck Temporary Coping acts as a basis for the fabrication of individual temporary restorations and small cemented temporary bridges on Straumann Standard Plus Implants 03.3mm Narrow Neck for use up to six months.
P.004 NC ANATOMIC ABUTMENTS
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations.
P.004 HEALING ABUTMENTS AND CLOSURE SCREWS
P.004 Healing Abutments and Closure Screws are intended for use with the Straumann P.004 Bone Level Implant system to protect the inner configuration of the implant. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process.
STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
P.004 ABUTMENTS
Both the P.004 RC/NC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
STRAUMANN P.004 CEMENTABLE ABUTMENTS TEMPORARY COPINGS AND PROTECTIVE CAPS
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.
Temporary Copings are intended to serve as a base for temporary restorations for up to 28 days.
P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Titanium
Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations.
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Ceramic
Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained.
P.004 NC GOLD ABUTMENT FOR CROWNS
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
P.004 ABUTMENTS
P.004 NC Temporary Abutment is indicated for use in Straumann P.004 NC Bone Level implants for temporary restorations of single crowns and bridges for up to six months.
P.004 NC Healing Abutment, customizable is indicated for use in Straumann P.004 NC Bone Level implants to protect the inner configuration of the implant and maintains, stabilizes and forms the soft tissue during the healing process for us to six months and should be placed out of occlusion.
SYNOCTA ABUTMENTS
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations.
P.004 ABUTMENTS P.004 TEMPORARY COPINGS
P.004 PROTECTIVE CAPS P.004 PERMANENT COPINGS
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures.
Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.
Copings are intended to serve as a base for multi-unit bar or bridge restorations.
Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months.
CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.
Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days.
P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures.
The P.004 NC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations.
The P.004 NC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained.
CONCAVE RN HEALING CAP
Healing Caps are intended for placement onto dental implants to protect the inner configuration and shoulder of the implant and to maintain, stabilize and form the soft tissue during the healing phase.
STRAUMANN DENTAL IMPLANT SYSTEM
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following: extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.
STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures.
The Straumann NN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.
The Straumann NN CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained or directly veneered.
STRAUMANN WN CARES TITANIUM ABUTMENT
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures.
The Straumann WN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.
STRAUMANN DENTAL IMPLANT SYSTEM
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with
appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients,
4 or more implants must be used in immediately loaded cases.
Specific indications for small diameter (0 3.3 mm) implants:
Because of their reduced mechanical stability; small diameter implants are only used in cases with a low mechanical load.
Placement in the molar region is not recommended.
STRAUMANN MODIFIED DENTAL ABUTMENT
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.
Modified Dental Implant Abutments are indicated for screw-retained single-tooth restorations and cement-retained single tooth and bridge restorations (via meso structures.)
STRAUMANN DENTAL ABUTMENTS
The Straumann NC Temporary Abutments are indicated for use in Straumann NC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.
STRAUMANN RC TEMPORARY ABUTMENTS
The Straumann RC Temporary Abutments are indicated for use in Straumann RC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.
STRAUMANN CARES BRIDGE;
STRAUMANN CARES DOLDER BAR
The Straumann® CARES® Screw-Retained Bridge and Straumann® CARES® Dolder® Bar indicated for use as bars and bridges that attach to dental implants (Straumann RN (Regular Neck) 0 4.8 mm and WN (Wide Neck) 0 6.5 mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
The Straumann CARES Screw-Retained Bridge can be designed for specific patient sizes and spans that are attached to 2
to 16 implants.
The Straumann CARES Dolder Bar can be designed for specific patient sizes and spans that are attached to 2 to 10
implants.
NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.
STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
Straumann® dental implants are suitable for the treatment of oral and endosteal implantation in the upper and lower jaw
and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific
indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or
early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on
single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal
loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full
dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the
posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more
implants must be used in immediately loaded cases.
Specific indications for small diameter (0 3.3 mm) implants:
Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load.
Placement in the molar region is not recommended.
STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM
STRAUMANN CARES DOLDER BAR TITANIUM
The Straumann® CARES® Screw-retained Bridge Titanium and Straumann® CARES® Dolder® Bar Titanium are
indicated for use as bars and bridges that attach to dental implants (Straumann Regular Neck (RN) 04.8mm and Wide
Neck (WN) 06.5mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
The Straumann® CARES® Screw-retained Bridge Titanium is available in different sizes and spans and can be fitted on 2
to 16 implants.
The Straumann® CARES® Dolder® Bar Titanium is available in different sizes and spans and can be fitted on 2 to 10
implants.
NNC CEMENTABLE ABUTMENT STRAIGHT15 DEGREE ANGLE TYPE A 15 DEGREE ANGLE TYPE B
NNC BASAL SCREW CEMENTABLE ABUTMENTS
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to
be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.
Narrow Neck CrossFit Cementable Abutments are indicated for cement-retained single tooth and bridge restorations.
NNC SOLID ABUTMENT
NNC TEMPORARY COPING FOR SOLID ABUTMENT
NNC TEMPORARY CAP FOR SOLID ABUTMENT
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to
be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.
Narrow Neck CrossFit Solid Abutments are indicated for cement-retained single tooth and bridge restorations.
NNC Gold Abutment For Bridges
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to
be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
STRAUMANN CARES Variobase Abutment NNC
STRAUMANN CARES Variobase Abutment RN
STRAUMANN CARES Variobase Abutment WN ST
The Straumann® CARES® Variobase ™ Abutment is a two-piece dental abutment consisting of the Straumann®
Variobase TM Abutment and the Straumann® CARES® Variobase™ Coping which is intended to be placed onto
Straumann dental implants to provide support for prosthetic reconstruction such as crowns and bridges. Straumann®
CARES® Variobase TM Abutments are indicated for screw-retained single tooth or cement-retained single tooth and
bridge restorations.
The Straumann® CARES® Variobase ™ Coping polycon® ae in combination with the Straumann® Variobase TM
Abutment is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant.
BL 04.1 MM RC SLACTIVE 8MM TIZR AND 10MM 12 14MM
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and
for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications
and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early
implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth
and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to
restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which
are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region,
we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used
in immediately loaded cases.
Straumann Temporary Abutments VITA CAD-Temp
Straumann Temporary Abutments VITA CAD-Temp are indicated for use with Straumann Bone Level and Tissue Level
implants for temporary crown and bridge restorations, and to maintain, stabilize and shape the soft tissue during the
healing phase for up to six months, and should be placed out of occlusion.
TL 04.1MM RNS SLActive TIZR 6 8 10 12 14 16MM Dental Implants
Straumann® dental Implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and
for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications
and limitations are present, as stated below). Straumann® dental Implants can also be used for Immediate or early
Implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on
single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal
loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full
dentures, which are connected to the Implants by the corresponding elements (abutments). When placing implants in the
posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more
implants must be used in immediately loaded cases.
Straumann Healing Abutments Healing Caps Closure Screws
Closure Screws, healing caps, and healing abutments, are Intended for use with the Straumann Dental Implant System
(SDIS) to protect the inner configuration of the Implant and maintain, stabilize and form the soft tissue during the healing
process.
Customizable healing abutments made of PEEK are for use for up to six months.
STRAUMANN Variobase Abutment NNC
STRAUMANN Variobase Abutment RN
STRAUMANN Variobase Abutment WN
The Straumann Variobase,. Abutment is a titanium base placed onto Straumann dental implants to provide support for
customized prosthetic restorations. Straumann Variobase. Abutments are indicated for screw-retained single tooth or
cement-retained single tooth and bridge restorations.
STRAUMANN CARES Bone Level Screw retained Bars
STRAUMANN CARES Bone Level Screw retained Bridges
Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and/
or to screw-retained abutments of the Straumann Dental Implant System (SDIS) to provide support for prosthetic
reconstructions such as bridges and over-dentures. The final processed products have the purpose of restoring chewing
function.
Straumann CARES Screw-Retained Bridges and Bars are indicated for screw retained restorations.
STRAUMANN Magellan(TM) Abutment Protective Cap Titanium Copings Gold Copings Basal Screw
The Straumann® Magellan TM abutments are indicated to be placed into Straumann® dental implants to provide support
for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Magellan™ abutments are indicated for screw-retained restorations.
STRAUMANN Cares Screw Retained Bars/Bridge
Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and/
or to screw-retained abutments of the Straumann Dental Implant System (SDIS) to provide support for prosthetic
reconstructions such as bridges and over-dentures. The final processed products have the purpose of restoring chewing
function.
Straumann CARES Screw-Retained Bridges and Bars are indicated for screw-retained restorations.
STRAUMANN Bone Level Tapered Implant
Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the
functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also
be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with
immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with
appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and
partial or full dentures, which are connected to the implants by the corresponding elements (abutments).
STRAUMANN Bone Level NC Angeled Screw Retained Abutments
The Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental
Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
Straumann Variobase Abutment NNC
Straumann Variobase Abutment RN
Straumann Variobase Abutment WN
Straumann Variobase Abutment NC
Straumann Variobase Abutment RC
IPS e.max CAD MO Coping IPS e.max CAD LT Crown IPS e.max CAD HT Crown coron CoCr Single Unit
The Straumann® Variobase™ Abutment is a titanium base placed onto Straumann dental implants to provide support for
customized prosthetic restorations. Straumann® Variobase™ Abutments are indicated for screw-retained single tooth or
cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the
Straumann® Variobase™ Abutment system are intended to be sent to Straumann for manufacture at a validated milling
center.
Straumann Screw Retained Abutment
The Straumann® Screw-Retained Abutments are indicated to be placed into Straumann dental implants to provide support
for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Straumann® Screw-Retained Abutments are indicated for screw-retained restorations.
Straumann CARES Titanium Alloy (TAN) Abutment
The Straumann CARES® TAN abutments are indicated for single tooth replacement and multiple tooth restorations. The
prosthetic restoration can be cemented or directly veneered/ screw-retained.
Straumann® Dental Implant System Roxolid® SLA Implants
Straumann dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional
and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for
immediate or early implantation following extraction or loss of natural teeth, Implants can be placed with immediate
function on single-tooth and /or multiple tooth applications when good primary stability is achieved and with appropriate
occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or
full dentures, which are connected to the implants by the corresponding elements (abutments).
NC Straumann Variobase Abutment for Bars/Bridges
RC Straumann Variobase Abutment for Bars/Bridges
NNC Straumann Variobase Abutment for Bars/Bridges RN
Straumann Variobase Abutment for Bars/Bridges WN
Straumann Variobase Abutment for Bars/Bridges
Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for
use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the
Straumann® Variobase™ prosthetic components. A temporary restoration can be used prior to the insertion of the final
components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into
occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
NC Straumann Screw Retained Abutments
The Straumann® Screw Retained Abutments are indicated to be placed into the NC and RC Bone Level implants of the
Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
Straumann Variobase CEREC
The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to
provide support for customized prosthetic
restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw-retained single tooth or cement-
retained single tooth and bridge restorations.
All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be
designed using Sirona inLab software
(Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or
inLab MC X or MC XL milling unit.
Straumann RN Gold Abutment for Bridge
Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in
prosthetic rehabilitations.
Straumann Bone Level Tapered Implants
Straumann® Bone Level Tapered Implants are indicated for oral endosteal implantation in the upper and lower jaw and
for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann Bone Level
Tapered Implants can also be used for immediate or early implantation following extraction or loss of natural teeth.
Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary
stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used
are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements
(abutments).
Straumann Sterile Healing Solution
Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental
Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the
healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in
conjunction with implant placement.
Straumann CARES Golden Ti/TiN Abutments
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or
overdentures.
The Straumann CARES Golden Ti/TiN Abutments are indicated for single tooth replacements and multiple tooth
restorations. The prosthetic restoration is cement-retained.
BLT 02.9mm SC SLA or SLActive RXD Loxim
SC Closure Cap and Healing Abutments
SC Temporary Abutments
SC Variobase Abutments SC CARES Abutment
Straumann® Bone Level Tapered Implants ∅2.9 mm are indicated for oral endosteal implantation in the upper and lower
jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level
Tapered Implants ∅2.9 mm can also be used for immediate or early implantation following extraction or loss of natural
teeth. Implants can be placed with immediate function on single-tooth or multiple-tooth applications when good primary
stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are
connected to the implants through the corresponding components (abutments).
The Straumann® Bone Level Tapered Implants ∅2.9 mm are indicated for reconstruction of missing incisors in the lower
jaw and lateral incisors in the upper jaw.
Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the
patient’s jaw to protect the inner configuration of the implant and to form, maintain and stabilize the soft tissue during the
healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant connection.
Straumann® SC Temporary Abutments are indicated for use as an aid in prosthetic rehabilitations. Temporary
components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue
during the healing phase. Straumann® SC Temporary Abutments have a maximum duration of usage of 180 days.
Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic
restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be
used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase.
Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally
designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to
Straumann for manufacture at a validated milling center.
Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The
prosthetic restoration can be cemented or directly veneered/screw-retained.
Straumann Screw Retained Abutments
Straumann Screw retained Abutments are indicated to be placed into the implants of the Straumann Dental Implant
System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices
have the purpose of restoring chewing function. Straumann Screw Retained Abutments are indicated for screw-retained
restorations.
ITI Distance System
This abutment system is intended to be used in conjunction with ITI endosseous dental implants to provide support for
prosthetic devices (crowns, bridges, overdentures) for the functional and oral rehabilitation of edentulous or partially
edentulous patients.
MEMFIX
The Memfix Screws are intended to be used to temporarily stabilize and fixate autogenous bone grafts and/or non
resorbable barrier membranes used for regeneration of bone in the oral cavity.
Titanium Healing Caps
Titanium healing caps are indicated for use with ITI Dental implants. They are used to allow the site to heal
Angled Abutment
The modified angled abutment is indicated for use in cases where the placement of the implant requires an angled
reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and
bridges for bound situations.
The angled abutment is not to be used in conjunction with the I'TI 15 degree angled implant as the total degree of
angulation is 30 degree or above.
The angled abutment is not to be used in conjuction with the ¥3.3 mm Solid Screw Implant for single, posterior
restorations.
Endosseous Dental Implant
Intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in
edentulous or partially edentulous patients.
Bonding Base
The bonding base is indicated for use with a standard I'TI implant placed in the posterior oral cavity, to serve as a base for
orthodontic attachment during orthodontic treatment.
Ortho Implant And Accessories
The Ortho implant of the Straumann Orthosystem is an endosseous implant intended for placement in the median palatal
region or in retro-molar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic
appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed
after orthodontic treatment has been completed.
Synocta Prosthetics
Prosthetic accessories are used in conjunction with I'TI dental implants in the prosthetic restoration of the implant. These
prosthetic accessories include abutments, copings and cylinders, and transfer system components. Abutments are placed
into the dental implants to provide support for prosthetic restorations such as crowns, bridges, and overdentures.
Prefabricated copings and cylinders provide a machined or cast inner surface for mating with the abutment and implant,
while the outer surface can be adapted to the individual restoration. Transfer system components are used in the process of
transferring the situation in the oral cavity to a precise dental model. Protection caps are used to protect the outer
configuration of the abutment and to maintain and condition the soft tissues during the prosthetic phase.
Synocta Angled Abutments
The synOcta® angled abutments are indicated for use in cases where the placement of the implant requires an angled
reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and
bridges for bound situations.
The angled abutment is not to be used in conjunction with the ITI 15° angled implant as the total degree of angulation is
30 degrees or above.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190662 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190662: MRI Compatibility for Existing Straumann Dental Implant Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190662
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026