510(k) · Cleared
Recalled · Class II · 2024Biohorizons Abutments for Zimmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BioHorizons Implant Systems, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 3, 2011 as substantially equivalent to K100985 (BioHorizons Implant Systems, Inc., 2010) and 8 other predicates after a 321-day review. Its family tree reaches back 12 generations to 1996. 45 later devices descend from it. It has been recalled once.
- Decided
- Nov 3, 2011
- Review
- 321 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 1
- Predicates
- 10
Its longest line of descent runs back 12 generations to K960026 (1996). 170 ancestors in all, the oldest K820013 (1982). 45 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations between
- 3 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 2 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 1 generation backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- This deviceK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011
- Descendant · cites it directly · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- Descendant · cites it directly · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- Descendant · 2 generations on · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- Descendant · cites it directly · 8 of its ownK203252 Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021
- Descendant · 3 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
Show all 12 generations
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 10 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 9 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 5 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 4 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 3 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 2 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 1 generation backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- This deviceK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · cites it directly36descendants
- K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · cites it directly25descendants
- K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · 2 generations on14descendants
- K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021 · cites it directly8descendants
- K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −11 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −5 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −4 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −3 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −2 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −1 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| 0 (this device) | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | — |
| +1 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| +1 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| +2 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| +1 | K203252 | Multi-unit Abutments for CONELOG | BioHorizons Implant Systems, Inc. | 2021 | — |
| +3 | K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 12 | 0 |
| 1994 | 13 | 0 |
| 1995 | 8 | 0 |
| 1996 | 12 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 11 | 0 |
| 2000 | 7 | 0 |
| 2001 | 8 | 0 |
| 2002 | 12 | 0 |
| 2003 | 9 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 9 | 0 |
| 2007 | 7 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 7 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100985 | Biohorizons Simple Solutions with Laser-LokSummary page 1…ment Classification Number: Class Il (21 CFR 872.3630) Predicate Devices 1. 2. 3. 8. 9. BioHorizons Simple Solutions with Laser-Lok, documented under 510(k) number K100985, concurrence date September 9, 2010. BioHorizons Internal Implant System, documented under 510(k) number K073268, concurrence da… | 2010 |
| * | K073268 | Biohorizons Internal Implant SystemSummary page 1…olutions with Laser-Lok, documented under 510(k) number K100985, concurrence date September 9, 2010. BioHorizons Internal Implant System, documented under 510(k) number K073268, concurrence date of February 8, 2008. BioHorizons Tapered Internal Implant System, documented under 510(k) number K071638, conc… | 2008 |
| * | K071638 | Biohorizons Tapered Internal Implant SystemSummary page 1…mplant System, documented under 510(k) number K073268, concurrence date of February 8, 2008. BioHorizons Tapered Internal Implant System, documented under 510(k) number K071638, concurrence date of October 10, 2007. Zimmer® Dental (formerly Sulzer Dental) Screw-Vent® and Tapered Screw-Vent® systems, docu… | 2007 |
| Kept off the family tree | K0013227 | Zimmer® Dental (formerly Sulzer Dental) Screw-Vent® and Tapered Screw-Vent®… Number could not be read | |
| * | K092403 | TI Prepable Abutment, Model 1618, 1619, 1620Summary page 1…Screw-Vent® systems, documented under 510(k) number KO013227, concurrence date of November 19, 2001. Zimmer Dental Ti Prepable Abutment, documented under 510(k) number K092403, concurrence date of October 30, 2009. Altatec GmbH CAMLOG Implant System Abutments, documented under 510(k) number K073553, con… | 2009 |
| * | K073553 | Camlog Implant System AbutmentsSummary page 1…ble Abutment, documented under 510(k) number K092403, concurrence date of October 30, 2009. Altatec GmbH CAMLOG Implant System Abutments, documented under 510(k) number K073553, concurrence date of March 5, 2008. Neoss Ltd. various Titanium Abutments, documented under 510(k) number K071838, concurrence d… | 2008 |
| * | K071838 | Neoss Various Titanium AbutmentsSummary page 1…plant System Abutments, documented under 510(k) number K073553, concurrence date of March 5, 2008. Neoss Ltd. various Titanium Abutments, documented under 510(k) number K071838, concurrence date of October 19, 2007. Altatec GmbH CAMLOG Implant System Modified Implants and Abutments, documented under 510(… | 2007 |
| * | K083496 | Camlog Implant System Modified Implants and AbutmentsSummary page 1…ed under 510(k) number K071838, concurrence date of October 19, 2007. Altatec GmbH CAMLOG Implant System Modified Implants and Abutments, documented under 510(k) number K083496, concurrence date of January 30, 2009. Sirona Dental CAD/CAM System, documented under 501(k) number K100152, concurrence date of… | 2009 |
| * | K100152 | Sirona Cad/Cam SystemSummary page 1…dified Implants and Abutments, documented under 510(k) number K083496, concurrence date of January 30, 2009. Sirona Dental CAD/CAM System, documented under 501(k) number K100152, concurrence date of October 22, 2010. 10.Thommen Medical AG SPI Titanium Base for CAD/CAM, documented under 510(k) number K102… | 2010 |
| * | K102804 | Spi Titanium Base for Cad/Cam Cleared while this submission was under review Summary page 1…stem, documented under 501(k) number K100152, concurrence date of October 22, 2010. 10.Thommen Medical AG SPI Titanium Base for CAD/CAM, documented under 510(k) number K102804, concurrence date of April 20, 2011. Device Description BioHorizons Abutments for Zimmer® are comprised of endosseous dental imp… | 2011 |
What descends from it? (45)
See all 453 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 6, 2024 | Class II | Z-1111-2025 | Component design/selection | Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 9 months on median.
- 23 of the 170 ancestors have a recall of any class.
- Of its descendants, K112440 (A.B. Dental Devices, Ltd., 2012) has gone furthest, with 36 descendants of its own.
- 1 other device also cites its predicate K100985.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
BioHorizons Abutments for Zimmer® are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The abutments may be used for a single or multiple unit restoration and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.
BioHorizons Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used to be used as straight abutments.
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/K103691 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103691: Biohorizons Abutments for Zimmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103691
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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