# Biocetec Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 4 (2017–2023): 4 510(k) clearances
- Product codes: NJM (3), OAT (1)
- 510(k) review time since 2016: median 173 days, against 192 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 2 (2 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
- 3M Unitek: 1 (https://510kreport.com/company/3m-unitek)
- Osstem Implant Co., Ltd.: 1 (https://510kreport.com/company/osstem-implant)

## Its most-cited devices
- K163467: C-Line Orthodontic Ceramic Bracket (2017), cited by 1
- K182193: S-Line (2019), cited by 1

## Recent decisions
- K231635: A-Line Advanced (Jun 6, 2023)
- K190871: Bio-TackS Orthodontic Mini Implant (Jan 17, 2020)
- K182193: S-Line (Jan 22, 2019)
- K163467: C-Line Orthodontic Ceramic Bracket (Jun 14, 2017)

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