# Bloomden Bioceramics (HuNan) Co., Ltd.

- Location (FDA's records): Changsha, CN
- FDA decisions: 2 (2021–2026): 2 510(k) clearances
- Product codes: EIH (2)
- Predicates its devices cite: 2 (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
- Zirkonzahn Srl: 1 (https://510kreport.com/company/zirkonzahn)

## Its most-cited devices
- K212765: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (2021), cited by 1

## Recent decisions
- K260370: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (Mar 30, 2026)
- K212765: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (Nov 15, 2021)

Source page: https://510kreport.com/company/bloomden-bioceramics-hunan