# Faico Medical, LLC

- Location (FDA's records): Boca Raton, FL
- FDA decisions: 3 (2020–2021): 3 510(k) clearances
- Product codes: JEY (1), NHA (1), DZE (1)
- 510(k) review time since 2016: median 249 days, against 211 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K211871: FAICO Dental Implant System and CAD/CAM Abutments (Nov 18, 2021)
- K191997: FAICO CMF System (Apr 22, 2020)
- K192015: Faico Dental Implant System (Apr 3, 2020)

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