# Bio Concept Co., Ltd.

- Location (FDA's records): Changzhou, CN
- FDA decisions: 3 (2015–2022): 3 510(k) clearances
- Product codes: DZE (3)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 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
- Straumann USA: 1 (https://510kreport.com/company/straumann-usa)
- Osstem Implant Co., Ltd.: 1 (https://510kreport.com/company/osstem-implant)

## Its most-cited devices
- K150388: Dental Implant System (2015), cited by 1

## Recent decisions
- K212364: BLT Dental Implant System (Aug 10, 2022)
- K192274: BV Dental Implant System (Jun 18, 2020)
- K150388: Dental Implant System (Nov 12, 2015)

Source page: https://510kreport.com/company/bio-concept