# Enpuno Biotechnology Co., Ltd.

- Location (FDA's records): Changsha High-Tech Development Zone Chan, CN
- FDA decisions: 2 (2024–2025): 2 510(k) clearances
- Product codes: KIF (2)
- Predicates its devices cite: 2 (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
- Innovative Bioceramix, Inc.: 1 (https://510kreport.com/company/innovative-bioceramix)
- Beijing C-Root Dental Medical Devices Co., Ltd.: 1 (https://510kreport.com/company/beijing-c-root-dental-medical-devices)

## Firms that cite its devices most
- Enpuno Co., Ltd.: 1 (https://510kreport.com/company/enpuno)

## Its most-cited devices
- K240304: Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) (2024), cited by 1

## Recent decisions
- K251465: Root canal repair materials (nRoot BP) (Sep 25, 2025)
- K240304: Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) (May 28, 2024)

Source page: https://510kreport.com/company/enpuno-biotechnology