Enpuno Biotechnology Co., Ltd.
Registered establishment in Changsha, Hunan, China. 1 device type, 2 clearances.
Enpuno Biotechnology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Resin, Root Canal Filling. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | ENPUNO BIOTECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3031606505 |
| FEI number | 3031606505 |
| Establishment type | Manufacturer |
Location
| City | Changsha |
|---|---|
| Province | Hunan |
| Address | No. 101,201,Haiping Park Production Plant 3,No.229, Guyuan Road Changsha High-tech Development Zone |
| Postal code | 410205 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Resin, Root Canal Filling | Class 2 | 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) | 2025 | 4 |
Clearances
2 clearances name Enpuno Biotechnology Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251465 | 2025-09-25 | KIF | Traditional | This company |
| K240304 | 2024-05-28 | KIF | Traditional | This company |
| K250710 | 2025-06-11 | KIF | Traditional | Enpuno Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | injectable root canal bioceramic sealer, bioceramic root repair material, restorative materials |
|---|---|
| Certifications | ISO 13485, CFDA, FDA, ANVISA, GMP |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.