# Biogenesis Co., Ltd.

- Location (FDA's records): Anaheim, CA
- FDA decisions: 2 (2013–2015): 2 510(k) clearances
- Product codes: DZE (2)
- Predicates its devices cite: 5 (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 whose devices it cites most
- Osstem Implant Co., Ltd.: 2 (https://510kreport.com/company/osstem-implant)
- Lifecore Biomedical, Inc.: 1 (https://510kreport.com/company/lifecore-biomedical)
- Dentium Co., Ltd.: 1 (https://510kreport.com/company/dentium)
- Megagen Co., Ltd.: 1 (https://510kreport.com/company/megagen)

## Firms that cite its devices most
- Modern Dental Laboratory (Dg) Co., Ltd.: 1 (https://510kreport.com/company/modern-dental-laboratory-dg)

## Its most-cited devices
- K142813: Biogensis Implant System-Kisses (2015), cited by 1

## Recent decisions
- K142813: Biogensis Implant System-Kisses (Jul 31, 2015)
- K120089: Biogenesis Implant System (Mar 13, 2013)

Source page: https://510kreport.com/company/biogenesis