# Biomet 3i, Inc.

- Location (FDA's records): Palm Beach Gardens, FL
- FDA decisions: 32 (2007–2025): 32 510(k) clearances
- Names in FDA's records: Biomet 3i, Inc. (13); Biomet 3i (12); Biomet 3i, LLC (7)
- Product codes: NHA (19), DZE (11), NUN (1), LYC (1)
- 510(k) review time since 2016: median 120 days, against 188 for FDA's reviews in the same codes and years (8 of 10 faster)
- Predicates its devices cite: 47 (19 its own); citations of its devices by later devices: 55 (19 its own)
- Recalls linked to its devices: 138 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Implant Innovations, Inc.: 18 (https://510kreport.com/company/implant-innovations)
- Bicon, Inc.: 3 (https://510kreport.com/company/bicon)
- Nobel Biocare Uas, Inc.: 2 (https://510kreport.com/company/nobel-biocare-uas)
- Nobel Biocare AB: 1 (https://510kreport.com/company/nobel-biocare)
- Zimmer Dental, Inc.: 1 (https://510kreport.com/company/zimmer-dental)
- Atlantis Components, Inc.: 1 (https://510kreport.com/company/atlantis-components)
- Implant Solutions Pty Ltd (Aka Osteon Medical): 1 (https://510kreport.com/company/implant-solutions-aka-osteon-medical)
- Terrats Medical SL: 1 (https://510kreport.com/company/terrats-medical)

## Firms that cite its devices most
- Sirona Dental Systems GmbH: 3 (https://510kreport.com/company/sirona-dental-systems)
- Zuga Medical, Inc.: 2 (https://510kreport.com/company/zuga-medical)
- Inclusive Dental Solutions: 2 (https://510kreport.com/company/inclusive-dental-solutions)
- Prismatik Dentalcraft, Inc.: 2 (https://510kreport.com/company/prismatik-dentalcraft)
- Southern Implants (Pty), Ltd.: 2 (https://510kreport.com/company/southern-implants)
- Biodenta Swiss AG: 1 (https://510kreport.com/company/biodenta-swiss)
- B.T.I. Biotechnology Institute, Sl.: 1 (https://510kreport.com/company/bti-biotechnology-institute)
- Intra-Lock International: 1 (https://510kreport.com/company/intra-lock-international)

## Its most-cited devices
- K072642: Biomet 3I Dental Abutments and Restorative Components (2007), cited by 12
- K133049: 3I T3(R) External Hex Dental Implants (2014), cited by 4
- K100724: Osseotite II Model Xifossxxx (2011), cited by 4
- K092341: Low Profile Abutments - Internal and External Connection (2009), cited by 4
- K072363: Nanotite Prevail,Certain,Parellel Walled,Tapered,External Hex (2008), cited by 3
- K080864: Cam Structsure Precision Milled Bars (2008), cited by 3

## Recent decisions
- K251660: T3 Pro Implants– ZimVie Packaging System (Jun 27, 2025)
- K241753: Immediate Molar Implants (Oct 23, 2024)
- K241032: BellaTek Bars (Jul 15, 2024)
- K220978: TSX Implants (Sep 14, 2022)
- K213672: T3 Pro Implants (Mar 28, 2022)
- K212730: BellaTek Encode Emergence Healing Abutments (Dec 21, 2021)
- K192522: TSV BellaTek Express and BellaTek Flex Abutments (Dec 9, 2019)
- K183138: Certain BellaTek Express and BellaTek Flex Abutments (Jul 2, 2019)

Source page: https://510kreport.com/company/biomet-3i