Not currently registered with FDA under this name
Enpuno Co., Ltd.
Changsha, China. Named as applicant on 1 dental 510(k) clearance between 2025 and 2025. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12025–2025
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2007–2026
510(k) clearances
Clearances on which FDA names Enpuno Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Jun 2025 | K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | KIF Root Canal Filling Resin |
Some of these clearances are listed with FDA today by another company: Enpuno Biotechnology Co., Ltd (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.