# K190662: MRI Compatibility for Existing Straumann Dental Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA, LLC
- Decided: Jun 17, 2019 after 94 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K192893: Straumann Ceramic Healing Abutments (2020), 1 descendant of its own
- K232383: iPhysio® System (2025), 0 descendants of its own
- K201681: Straumann Immediate Temporary Abutments (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K190662
Methodology: https://510kreport.com/methodology