# Bonafix Surgical and Dental Implants, LLC

- Location (FDA's records): 118 W Prive Cr., FL
- FDA decisions: 3 (2012–2017): 3 510(k) clearances
- Names in FDA's records: Bonafix Surgical and Dental Implants, LLC (2); Bonafix Surgical and Dental Implants (1)
- Product codes: DZE (2), OAT (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Jeil Medical Corporation: 1 (https://510kreport.com/company/jeil-medical)
- Mis - Implant Technologies, Ltd.: 1 (https://510kreport.com/company/mis-implant-technologies)
- Imtec Corp.: 1 (https://510kreport.com/company/imtec)
- Prismatik Dentalcraft, Inc.: 1 (https://510kreport.com/company/prismatik-dentalcraft)
- Intra-Lock International: 1 (https://510kreport.com/company/intra-lock-international)

## Firms that cite its devices most
- Blue Sky Bio, LLC: 1 (https://510kreport.com/company/blue-sky-bio)

## Its most-cited devices
- K113650: Orthofix Screw (2012), cited by 1

## Recent decisions
- K162853: Bonafix TWO - Dental Implant System (Jul 14, 2017)
- K122052: Minifix Ball Minifix One (Nov 28, 2012)
- K113650: Orthofix Screw (Oct 3, 2012)

Source page: https://510kreport.com/company/bonafix-surgical-and-dental-implants