Data / Medical devices / China / Enpuno Biotechnology Co., Ltd
Enpuno Biotechnology Co., Ltd: FDA-registered device maker in Changsha Hunan, China, 2 510(k) clearances
Enpuno Biotechnology Co., Ltd is registered with the FDA (registration 3031606505) in Changsha Hunan, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 25, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031606505
- Address
- No. 101,201,Haiping Park Production Plant 3,No.229, Guyuan Road Changsha High-tech Development Zone, Changsha Hunan, China, 410205
- Owner or operator
- Enpuno Biotechnology Co., Ltd (10090947)
- Roles
- Manufacturer
- First device listed
- June 15, 2025
- Registered through
- 2026
- Brand names listed
- Injectable Root Canal Bioceramic Sealer(nRoot SP),NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5, Root canal repair materials (nRoot BP)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Resin, Root Canal Filling | KIF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 25, 2025 | K251465 | Root canal repair materials (nRoot BP) | KIF | Substantially Equivalent | Enpuno Biotechnology Co., Ltd. | accessdata.fda.gov |
| June 11, 2025 | K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | KIF | Substantially Equivalent | Enpuno Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.