# Zentek Medical, LLC

- Location (FDA's records): Manalapan, NJ
- FDA decisions: 3 (2022–2025): 3 510(k) clearances
- Product codes: NHA (2), DZE (1)
- 510(k) review time since 2016: median 393 days, against 147 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 3 (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
- Talladium España, SL: 1 (https://510kreport.com/company/talladium-espana)
- Medical Systems and Devices International, Ltd.: 1 (https://510kreport.com/company/medical-systems-and-devices-international)

## Its most-cited devices
- K221673: Bonafix TiBase (2023), cited by 1

## Recent decisions
- K251294: Bonafix Implant Abutments (Oct 15, 2025)
- K221673: Bonafix TiBase (Jul 14, 2023)
- K213677: Bonafix 2 Plus (Dec 20, 2022)

Source page: https://510kreport.com/company/zentek-medical