# K103691: Biohorizons Abutments for Zimmer

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Nov 3, 2011 after 321 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K960026 (1996). 170 ancestors in all.
45 later devices descend from it; 3 cite it directly.
0 of 216 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100985: Biohorizons Simple Solutions with Laser-Lok, BioHorizons Implant Systems, Inc. (2010) Summary page 1.
- K073268: Biohorizons Internal Implant System, BioHorizons Implant Systems, Inc. (2008) Summary page 1.
- K071638: Biohorizons Tapered Internal Implant System, BioHorizons Implant Systems, Inc. (2007) Summary page 1.
- K092403: TI Prepable Abutment, Model 1618, 1619, 1620, Zimmer Dental, Inc. (2009) Summary page 1.
- K073553: Camlog Implant System Abutments, Altatec GmbH (2008) Summary page 1.
- K071838: Neoss Various Titanium Abutments, Neoss, Ltd. (2007) Summary page 1.
- K083496: Camlog Implant System Modified Implants and Abutments, Altatec GmbH (2009) Summary page 1.
- K100152: Sirona Cad/Cam System, Sirona Dental Systems GmbH (2010) Summary page 1.
- K102804: Spi Titanium Base for Cad/Cam, Thommen Medical AG (2011). Cleared while this submission was under review Summary page 1.

## Cited in the summary but kept off the family tree
- K0013227: Zimmer® Dental (formerly Sulzer Dental) Screw-Vent® and Tapered Screw-Vent® systems. Number could not be read

## Most influential descendants
- K112440: AB Dental Devices Implants and Accessories (2012), 36 descendants of its own
- K132125: A.B. Dental Devices Dental Implants System (2014), 25 descendants of its own
- K140440: Noris Medical Dental Implants System (2014), 14 descendants of its own
- K203252: Multi-unit Abutments for CONELOG (2021), 8 descendants of its own
- K151909: Noris Medical Zygomatic Dental Implant System (2016), 7 descendants of its own

## Recalls of this device
- Dec 6, 2024 · Class II · Z-1111-2025: 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 fractur

## Indications for use
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.

Source page: https://510kreport.com/device/K103691
Methodology: https://510kreport.com/methodology