# Biotech One, Inc.

- Location (FDA's records): Laguna Niguel, CA
- FDA decisions: 2 (2004–2006): 2 510(k) clearances
- Product codes: JEY (1), MVL (1)
- Predicates its devices cite: 0 (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 that cite its devices most
- Prosurg, Inc.: 1 (https://510kreport.com/company/prosurg)

## Its most-cited devices
- K040650: Bonamates Series (2004), cited by 1

## Recent decisions
- K053329: Korlex-GR Gingival Retraction Paste (Feb 15, 2006)
- K040650: Bonamates Series (Jun 3, 2004)

Source page: https://510kreport.com/company/biotech-one