Manufacturer registered with FDA
Yilink (Tianjin) Biotechnology Co., Ltd.
Tianjin, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 5
- 510(k) clearances
- 32022–2024
- Markets registered in
- 29 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Yilink (Tianjin) 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 | Yilink (Tianjin) Biotechnology Co., Ltd. | 3 clearances | 2022–2024 | Below |
| European Union | EUDAMED | Manufacturer | Yilink (Tianjin) Biotechnology Co., Ltd | 9 | — | 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 Yilink (Tianjin) 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Dental Glass-Ceramic BlockDental porcelain powderDental Zirconia Ceramic BlockGlass CeramicsZirconia Block | 2022 |
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 Yilink (Tianjin) Biotechnology Co., Ltd. as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Yilink (Tianjin) Biotechnology Co., Ltd.FDA reg. 3025436468 | Tianjin, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086569). 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.