Manufacturer registered with FDA
Enpuno Biotechnology Co., Ltd
Changsha, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 22024–2025
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Enpuno Biotechnology Co., Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Enpuno Biotechnology Co., Ltd | 2 clearances | 2024–2025 | Below |
| Brazil | ANVISA | Manufacturer | ENPUNO BIOTECHNOLOGY CO., LTD. | 2 | 2025–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ENPUNO BIOTECHNOLOGY CO., LTD | 1 | 2026–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Enpuno Biotechnology Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | Injectable Root Canal Bioceramic Sealer(nRoot SP),NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5Root canal repair materials (nRoot BP) | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Enpuno Biotechnology Co., Ltd as the applicant.
Also lists devices cleared under other names
Enpuno Biotechnology Co., Ltd lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Enpuno Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Jun 2025 | K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | Enpuno Co., Ltd. | KIF Root Canal Filling Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ENPUNO BIOTECHNOLOGY CO., LTDFDA reg. 3031606505 | Changsha Hunan, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090947). 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.