Manufacturer registered with FDA
Baot Biological Technology Co., Ltd.
Zhongshan, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 3
- 510(k) clearances
- 12019–2019
- Markets registered in
- 524 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Baot Biological Technology 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 | Baot Biological Technology Co., Ltd. | 1 clearances | 2019–2019 | Below |
| Saudi Arabia | SFDA | Manufacturer | BAOT BIOLOGICAL TECHNOLOGY | 19 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BAOT BIOLOGICAL TECHNOLOGY CO., LTD | 3 | 2016–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | BAOT Biological Technology Co., Ltd. | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BAOT Biological Technology Co., Ltd. | 1 | 2019–2019 | 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 Baot Biological Technology 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Dental CeramicDental PorcelainFormative Liquid | 2019 |
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 |
|---|---|---|
| BAOT BIOLOGICAL TECHNOLOGY CO., LTD.FDA reg. 3014311922 | Zhongshan Guangdong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060584). 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.