Data / Medical devices / China / Baot Biological Technology Co., Ltd.
Baot Biological Technology Co., Ltd.: FDA-registered device maker in Zhongshan Guangdong, China, 1 510(k) clearance
Baot Biological Technology Co., Ltd. is registered with the FDA (registration 3014311922) in Zhongshan Guangdong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 22, 2019. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3014311922
- Address
- Unit 1 First Floor, Second Floor and Unit 3 Fourth Floor, No. 12 Building, 106 Qihao Road Torch Development District, Zhongshan Guangdong, China, 528437
- Owner or operator
- BAOT BIOLOGICAL TECHNOLOGY CO., LTD. (10060584)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- May 29, 2019
- Registered through
- 2026
- Brand names listed
- Dental Ceramic, Dental Porcelain, Formative Liquid
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 22, 2019 | K182350 | Dental Ceramic | EIH | Substantially Equivalent | Baot Biological Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 22, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.