# Paragon Implant Mfg., LLC

- Location (FDA's records): Calabasas, CA
- FDA decisions: 5 (2025–2026): 5 510(k) clearances
- Product codes: DZE (4), KCT (1)
- 510(k) review time since 2016: median 158 days, against 184 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 1 (1 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
- Implant Direct Sybron Manufacturing, LLC: 3 (https://510kreport.com/company/implant-direct-sybron-manufacturing)
- Implant Direct, LLC: 1 (https://510kreport.com/company/implant-direct)
- Terrats Medical SL: 1 (https://510kreport.com/company/terrats-medical)

## Its most-cited devices
- K251938: GEN5 and GEN5+ Dental Implant System (2025), cited by 1

## Recent decisions
- K261392: TriActive Dental Implant System (Sep 17, 2026)
- K252145: GEN5™ and GEN5+™ 3.3mmD Dental Implants (Dec 23, 2025)
- K250476: NizPlant Dental Implant System (Dec 23, 2025)
- K251756: Sterilization Trays (Nov 14, 2025)
- K251938: GEN5 and GEN5+ Dental Implant System (Oct 30, 2025)

Source page: https://510kreport.com/company/paragon-implant-mfg