510(k) · Cleared
ClearedStraumann Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · DZE Implant, Endosseous, Root-Form
Cleared on Feb 26, 2009 as substantially equivalent to K053088 (Institut Straumann AG, 2006) and 1 other predicate after an 87-day review. Its family tree reaches back 8 generations to 1990. 228 later devices descend from it.
- Decided
- Feb 26, 2009
- Review
- 87 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K894595 (1990). 40 ancestors in all, the oldest K894844 (1990). 228 later devices descend from it, 9 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 5 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 2 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 1 generation backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- This deviceK083550 Straumann Dental Implant SystemStraumann USA · 2009
- Descendant · cites it directly · 222 of its ownK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- Descendant · 2 generations on · 166 of its ownK113283 NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree…Straumann USA · 2011
- Descendant · cites it directly · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · 2 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · cites it directly · 124 of its ownK121131 BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA · 2012 · Recalled
Showing 5 of 228 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 228 · See all- K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011 · cites it directly222descendants
- K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA · 2011 · 2 generations on166descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · cites it directly165descendants
- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 2 generations on129descendants
- K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA · 2012 · cites it directly124descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −5 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −2 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −1 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| 0 (this device) | K083550 | Straumann Dental Implant System | Straumann USA | 2009 | — |
| +1 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| +2 | K113283 | NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle… | Straumann USA | 2011 | — |
| +1 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +2 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +1 | K121131 | BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM | Straumann USA | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 10 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 14 | 0 |
| 2019 | 11 | 0 |
| 2020 | 18 | 0 |
| 2021 | 24 | 0 |
| 2022 | 16 | 0 |
| 2023 | 29 | 0 |
| 2024 | 30 | 0 |
| 2025 | 27 | 0 |
| 2026 | 16 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053088 | Slactive ImplantsSummary page 1…mber: 21 CFR 872.3640 3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Straumann Dental Implant System, K053088 and K062129 4. Description of the Device The Straumann Dental Implant System is an integrated system of end… | 2006 |
| * | K062129 | P.0004 ImplantsSummary page 1…21 CFR 872.3640 3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Straumann Dental Implant System, K053088 and K062129 4. Description of the Device The Straumann Dental Implant System is an integrated system of endosseous dent… | 2006 |
What descends from it? (228)
See all 2289 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | 2011 | 222 |
| K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann… | 2012 | 165 |
| K121131 | BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM | 2012 | 124 |
| K122855 | TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental Implants | 2012 | 123 |
| K123784 | Straumann Dental Implant System | 2013 | 122 |
| K130222 | Straumann Dental Implant System | 2013 | 118 |
| K140878 | Straumann Bone Level Tapered Implant | 2014 | 105 |
| K130216 | Atlantis Straumann Bone Level Abutment | 2013 | 0 |
| K092261 | Defcon Tsa/TSH Dental Implant System | 2010 | 0 |
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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 40 ancestors have a recall of any class.
- Of its descendants, K111357 (Straumann USA, 2011) has gone furthest, with 222 descendants of its own.
- 9 other devices also cite its predicate K053088.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
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…
Read the full statement (180 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083550: Straumann Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083550
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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