Manufacturer registered with FDA
Ningbo Sinyuan Bur & Tool Co.,Ltd.
Ningbo, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 812 registrations outside the US
- Establishments
- 1China
Registered in 8 markets
Where regulators' registries name Ningbo Sinyuan Bur & Tool 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 | Ningbo Sinyuan Bur & Tool Co.,Ltd. | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Ningbo Sinyuan Bur & Tool Co., Ltd. | 4 | 2013–2024 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | NINGBO SINYUAN BUR &TOOL CO., LTD. | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | NINGBO SINYUAN BUR & TOOL CO., LTD | 2 | 2014–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | Ningbo Sinyuan Bur & Tool Co Ltd | 1 | 2023–2023 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Ningbo Sinyuan Bur & Tool Co., Ltd | 1 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Ningbo Sinyuan Bur & Tool Co., Ltd. | 1 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Ningbo Sinyuan Bur & Tool Co. Ltd. | 1 | — | 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 Ningbo Sinyuan Bur & Tool 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 |
|---|---|---|---|---|
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental Burs | 2012 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NINGBO SINYUAN BUR & TOOL CO.,LTD.FDA reg. 3010021780 | Ningbo Zhejiang, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042749). 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.