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Sign in to claim this brandEnpuno Biotechnology Co., Ltd.
US
Last updated May 23, 2026
What Enpuno Biotechnology Co., Ltd. makes
Enpuno Biotechnology Co., Ltd. manufactures injectable root canal bioceramic sealers (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) and root canal repair materials (nRoot BP).
The company's products are Class II devices listed in the FDA 510(k) registry, and the company is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Enpuno Biotechnology Co., Ltd. manufacture?
Enpuno Biotechnology Co., Ltd. manufactures injectable root canal bioceramic sealers (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) and root canal repair materials (nRoot BP). These are dental devices used in root canal procedures.
Where is Enpuno Biotechnology Co., Ltd. based?
Enpuno Biotechnology Co., Ltd. is based in the United States. The company operates from this location to develop and manufacture its dental devices for the market.
Which regulatory registries list Enpuno Biotechnology's devices?
Enpuno Biotechnology's devices are listed in the FDA 510(k) registry. This registry contains information about medical devices that have been cleared for marketing in the United States through the 510(k) process.
How are Enpuno Biotechnology's devices classified?
Enpuno Biotechnology's devices are classified as Class II medical devices. Class II devices are those that require more regulatory control than Class I devices but less than Class III devices, and they typically require special controls to ensure their safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- FDA FEI Number
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- DUNS Number
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Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Injectable Root Canal Bioceramic Sealer(nRoot SP) | NR SP-0.5 | FDA UDI | Class II | Active |
| Injectable Root Canal Bioceramic Sealer(nRoot SP) | NR SP-3 | FDA UDI | Class II | Active |
| Injectable Root Canal Bioceramic Sealer | NR SP-2 | FDA UDI | Class II | Active |
| Injectable Root Canal Bioceramic Sealer | NR SP-3 | FDA UDI | Class II | Active |
| Injectable Root Canal Bioceramic Sealer | NR SP-1 | FDA UDI | Class II | Active |
| Injectable Root Canal Bioceramic Sealer(nRoot SP) | NR SP-2 | FDA UDI | Class II | Active |
| Injectable Root Canal Bioceramic Sealer | NR SP-0.5 | FDA UDI | Class II | Active |
| Injectable Root Canal Bioceramic Sealer(nRoot SP) | NR SP-5 | FDA UDI | Class II | Active |
| Injectable Root Canal Bioceramic Sealer | NR SP-5 | FDA UDI | Class II | Active |
| Injectable Root Canal Bioceramic Sealer(nRoot SP) | NR SP-1 | FDA UDI | Class II | Active |
| Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) | K240304 | FDA 510(k) | Class II | Active |
| Root canal repair materials (nRoot BP) | K251465 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Enpuno Biotechnology Co., Ltd Changsha Hunan · CN FEI 3031606505