# BioHorizons Implant Systems, Inc.

- Location (FDA's records): Birmingham, AL
- FDA decisions: 41 (1996–2026): 41 510(k) clearances
- Product codes: DZE (26), NHA (12), DZL (3)
- 510(k) review time since 2016: median 162 days, against 201 for FDA's reviews in the same codes and years (5 of 10 faster)
- Predicates its devices cite: 118 (76 its own); citations of its devices by later devices: 119 (76 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Altatec GmbH: 8 (https://510kreport.com/company/altatec)
- Imtec Corp.: 4 (https://510kreport.com/company/imtec)
- Astra Tech, Inc.: 3 (https://510kreport.com/company/astra-tech)
- Zimmer Dental, Inc.: 2 (https://510kreport.com/company/zimmer-dental)
- Neoss, Ltd.: 2 (https://510kreport.com/company/neoss)
- Sirona Dental Systems GmbH: 2 (https://510kreport.com/company/sirona-dental-systems)
- Thommen Medical AG: 2 (https://510kreport.com/company/thommen-medical)
- Nobel Biocare AB: 2 (https://510kreport.com/company/nobel-biocare)

## Firms that cite its devices most
- Cendres & Metaux SA: 5 (https://510kreport.com/company/cendres-metaux)
- Intra-Lock International: 4 (https://510kreport.com/company/intra-lock-international)
- A.B. Dental Devices, Ltd.: 2 (https://510kreport.com/company/ab-dental-devices)
- Csm Implant: 2 (https://510kreport.com/company/csm-implant)
- Atlantis Components, Inc.: 2 (https://510kreport.com/company/atlantis-components)
- Titan Implants: 2 (https://510kreport.com/company/titan-implants)
- Alpha-Bio Tec, Ltd.: 2 (https://510kreport.com/company/alpha-bio-tec)
- Preat Corporation: 1 (https://510kreport.com/company/preat)

## Its most-cited devices
- K071638: Biohorizons Tapered Internal Implant System (2007), cited by 12
- K073268: Biohorizons Internal Implant System (2008), cited by 8
- K010458: The Maestro System (2001), cited by 8
- K032351: The Maestro System 3.0MM Diameter Implant (2003), cited by 7
- K960026: Biohorizons Dental Implant System (1996), cited by 7
- K964330: Biohorizons Dental Implant System (Name Subject to Change) (1997), cited by 6

## Recent decisions
- K260061: BioHorizons CEREC Compatible Ti-Bases (Jun 26, 2026)
- K243521: Conical Ti Base abutments (May 1, 2025)
- K240531: SmartShape™  Healing Abutment; Wide Custom Milled Ti-Blank Abutment (Jul 30, 2024)
- K240187: Tapered Pro Conical Implant System (Jun 5, 2024)
- K223697: MRI compatibility for existing BioHorizons dental implants and abutments (Oct 13, 2023)
- K203252: Multi-unit Abutments for CONELOG (Mar 16, 2021)
- K182070: BioHorizons Tapered IM Implants (Oct 10, 2018)
- K180998: BioHorizons CAD/CAM Bars (Sep 28, 2018)

Source page: https://510kreport.com/company/biohorizons-implant-systems