Data / Medical devices / China / Yilink (Tianjin) Biotechnology Co., Ltd.
Yilink (Tianjin) Biotechnology Co., Ltd.: FDA-registered device maker in Tianjin, China, 3 510(k) clearances
Yilink (Tianjin) Biotechnology Co., Ltd. is registered with the FDA (registration 3025436468) in Tianjin, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated October 10, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025436468
- Address
- workshop 1-102, No. 5 Fengze Fourth Avenue, Balitai Town, Jinnan District, Tianjin, China, 300350
- Owner or operator
- Yilink (Tianjin) Biotechnology Co., Ltd. (10086569)
- Roles
- Manufacturer
- First device listed
- November 20, 2022
- Registered through
- 2026
- Brand names listed
- Dental Glass-Ceramic Block, Dental Zirconia Ceramic Block, Dental porcelain powder, Glass Ceramics, Zirconia Block
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | 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 |
|---|---|---|---|---|---|---|
| October 10, 2024 | K242400 | Dental porcelain powder | EIH | Substantially Equivalent | Yilink (Tianjin) Biotechnology Co., Ltd. | accessdata.fda.gov |
| February 10, 2023 | K222513 | Glass Ceramics | EIH | Substantially Equivalent | Yilink (Tianjin) Biotechnology Co., Ltd. | accessdata.fda.gov |
| November 14, 2022 | K222520 | Zirconia Block | EIH | Substantially Equivalent | Yilink (Tianjin) Biotechnology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 10, 2024. 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.