510(k) · Cleared
ClearedThommen Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thommen Medical AG · DZE Implant, Endosseous, Root-Form
Cleared on Sep 29, 2017 as substantially equivalent to K093615 (Thommen Medical AG, 2010) and 5 other predicates after a 105-day review. Its family tree reaches back 15 generations to 1996.
- Decided
- Sep 29, 2017
- Review
- 105 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 15 generations to K960026 (1996). 280 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 15 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations between
- 3 generations backK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
- 2 generations backK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
- 1 generation backK151984 Thommen Milling Abutment for CAD/CAMThommen Medical AG · 2016
- This deviceK171795 Thommen Implant SystemThommen Medical AG · 2017
Show all 15 generations
- Root · 15 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 14 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 13 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 12 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 8 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 7 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 6 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 5 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 4 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 3 generations backK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
- 2 generations backK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
- 1 generation backK151984 Thommen Milling Abutment for CAD/CAMThommen Medical AG · 2016
- This deviceK171795 Thommen Implant SystemThommen Medical AG · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −14 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −13 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −12 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −8 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −7 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −6 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −5 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −4 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| −3 | K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | BioHorizons Implant Systems, Inc. | 2011 | — |
| −2 | K122295 | Core 3D Abutment System for Digital Prosthetic Solutions | Core 3D Protech, S.L. | 2013 | — |
| −1 | K151984 | Thommen Milling Abutment for CAD/CAM | Thommen Medical AG | 2016 | — |
| 0 (this device) | K171795 | Thommen Implant System | Thommen Medical AG | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 4 | 0 |
| 1992 | 5 | 0 |
| 1993 | 14 | 0 |
| 1994 | 13 | 0 |
| 1995 | 12 | 0 |
| 1996 | 16 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 12 | 0 |
| 2000 | 9 | 0 |
| 2001 | 12 | 0 |
| 2002 | 19 | 0 |
| 2003 | 16 | 0 |
| 2004 | 15 | 0 |
| 2005 | 12 | 0 |
| 2006 | 12 | 0 |
| 2007 | 13 | 0 |
| 2008 | 11 | 0 |
| 2009 | 13 | 0 |
| 2010 | 8 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2016 | 1 | 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? (6)
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 |
|---|---|---|---|
| * | K093615 | Spi Dental Implant, ElementSummary page 4…DZE, NHA Classification Panel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate K093615, SPI® Dental Implant ELEMENT, Thommen Medical AG Reference Predicates K160244, VARIOunite, Thommen Medical AG K102804, SPI® Tita… | 2010 |
| * | K160244 | VARIOuniteSummary page 4…nch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate K093615, SPI® Dental Implant ELEMENT, Thommen Medical AG Reference Predicates K160244, VARIOunite, Thommen Medical AG K102804, SPI® Titanium Base for CAD/CAM, Thommen Medical AG K151984, Milling Abutment for CAD/CAM… | 2016 |
| * | K102804 | Spi Titanium Base for Cad/CamSummary page 4…ch PREDICATE DEVICE INFORMATION Primary Predicate K093615, SPI® Dental Implant ELEMENT, Thommen Medical AG Reference Predicates K160244, VARIOunite, Thommen Medical AG K102804, SPI® Titanium Base for CAD/CAM, Thommen Medical AG K151984, Milling Abutment for CAD/CAM, Thommen Medical AG K121334, VARIOeco,… | 2011 |
| * | K151984 | Thommen Milling Abutment for CAD/CAMSummary page 4…SPI® Dental Implant ELEMENT, Thommen Medical AG Reference Predicates K160244, VARIOunite, Thommen Medical AG K102804, SPI® Titanium Base for CAD/CAM, Thommen Medical AG K151984, Milling Abutment for CAD/CAM, Thommen Medical AG K121334, VARIOeco, Thommen Medical AG K120414, OsseoSpeed™ Plus, Astra Tech AB… | 2016 |
| * | K121334 | VarioecoSummary page 4…Predicates K160244, VARIOunite, Thommen Medical AG K102804, SPI® Titanium Base for CAD/CAM, Thommen Medical AG K151984, Milling Abutment for CAD/CAM, Thommen Medical AG K121334, VARIOeco, Thommen Medical AG K120414, OsseoSpeed™ Plus, Astra Tech AB 510(k) Summary… | 2012 |
| * | K120414 | Osseospeed PlusSummary page 4…en Medical AG K102804, SPI® Titanium Base for CAD/CAM, Thommen Medical AG K151984, Milling Abutment for CAD/CAM, Thommen Medical AG K121334, VARIOeco, Thommen Medical AG K120414, OsseoSpeed™ Plus, Astra Tech AB 510(k) Summary… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 31 of the 280 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Implant: The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation and restoration in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and the central and lateral incisors of the…
Read the full statement (187 words)
Implant:
The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation and restoration in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and the central and lateral incisors of the lower jaw.
VARIOunite PF 3.0:
Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth).
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.
VARIOunite:
Thommen Medical VARIOunite abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171795: Thommen 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/K171795
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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