# Biotem Co., Ltd.

- Location (FDA's records): Busan, KR
- FDA decisions: 6 (2017–2023): 6 510(k) clearances
- Product codes: DZE (6)
- 510(k) review time since 2016: median 310 days, against 227 for FDA's reviews in the same codes and years (1 of 6 faster)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 3 (3 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)
- Neobiotech Co., Ltd.: 1 (https://510kreport.com/company/neobiotech)

## Its most-cited devices
- K171185: IR Type Implant System (2017), cited by 1
- K171179: BR Type Implant System (2018), cited by 1
- K171297: AR_N Type Implant System (2018), cited by 1

## Recent decisions
- K222142: BR SLA Type Implant System (Jun 24, 2023)
- K222144: IR SLA Type Implant System (Jun 14, 2023)
- K190641: AR_N SLA Type Implant System (Feb 21, 2020)
- K171179: BR Type Implant System (Feb 9, 2018)
- K171297: AR_N Type Implant System (Jan 31, 2018)
- K171185: IR Type Implant System (Dec 1, 2017)

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