Yilink (Tianjin) Biotechnology Co., Ltd.
Manufacturer and brand owner in Tianjin, China. 1 device type, 3 products catalogued, 3 clearances.
Yilink (Tianjin) Biotechnology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Powder, Porcelain. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
1device type
3products catalogued under its own name
3510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3025436468 |
| FEI number | 3025436468 |
| DUNS | 602190359 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 壹凌（天津）生物科技有限公司 |
|---|---|
| Unified social credit code | 91120112MA078Q26X0 |
| Source | NMPA UDI database |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | workshop 1-102, No. 5 Fengze Fourth Avenue, Balitai Town, Jinnan District |
| Postal code | 300350 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Powder, Porcelain | Class 2 | Dental porcelain powder, Glass Ceramics, Dental Glass-Ceramic Block, Zirconia Block, Dental Zirconia Ceramic Block | 2022 | 33 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Dental Zirconia Ceramic Block | EIH | 15 |
| Dental Porcelain Powder | EIH | 3 |
| Dental Glass-ceramic Block | EIH | 3 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242400 | 2024-10-10 | EIH | Traditional | This company |
| K222513 | 2023-02-10 | EIH | Traditional | This company |
| K222520 | 2022-11-14 | EIH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Employees | 150+ |
| Factory area | 2,100 square meters |
| Main products | Zirconia dental materials, Dental CAD/CAM equipment, Glass ceramics, PMMA, Dental milling equipment |
| Export markets | 60+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.