Not currently registered with FDA under this name
Chengdu Besmile Biotechnology Co., Ltd.
Chengdu, China. Named as applicant on 1 dental 510(k) clearance between 2017 and 2017. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12017–2017
- Markets registered in
- 516 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Chengdu Besmile 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 | Applicant | Chengdu Besmile Biotechnology Co., Ltd. | 1 clearances | 2017–2017 | Below |
| Brazil | ANVISA | Manufacturer | CHENGDU BESMILE BIOTECHNOLOGY CO., LTD | 11 | 2024–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Chengdu Besmile Biotechnology Co.,Ltd | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Chengdu Besmile Biotechnology Co., Ltd. | 2 | 2025–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Chengdu Besmile Biotechnology Co Ltd | 1 | 2017–2017 | 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
510(k) clearances
Clearances on which FDA names Chengdu Besmile Biotechnology Co., Ltd. as the applicant.
Some of these clearances are listed with FDA today by another company: Chengdu Besmile Medical Technology Co., Ltd. (1), Megagen Implant Co., Ltd. (1).
Sources
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 of the most recent filing, which can be a US agent.