Registered establishment in Changchun, Jilin, China. 2 device types, 1 clearance.
Sino-Dentex Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Agent, Tooth Bonding, Resin, Material, Tooth Shade, Resin. Its earliest product listing with the FDA dates from 2021.
Registration
FDA registration record for Sino-Dentex Co., Ltd. | Registered name | SINO-DENTEX CO.,LTD |
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3018283083 |
| FEI number | 3018283083 |
| Establishment type | Manufacturer |
Chinese Registration
Chinese company register details for Sino-Dentex Co., Ltd. | Chinese legal name | 吉林省登泰克牙科材料有限公司 |
| Unified social credit code | 91220101778733782H |
| Source | NMPA UDI database |
Location
Address of Sino-Dentex Co., Ltd. | City | Changchun |
| Province | Jilin |
| Address | 721 Chenggong Road High-Tech Development District |
| Postal code | 130000 |
| Country | China |
Clearances
1 clearance names Sino-Dentex Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
From the Company
Published by the company on its own website, not by the FDA.
Information published by Sino-Dentex Co., Ltd. | Founded | 2005 |
| Main products | Resin materials, Adhesive materials, Temporary materials, Bio PAEK, Composite ceramics |
| Certifications | 吉林省科学技术奖, 国家重点新产品奖, National High-Tech Enterprise, Specialized Refined Special and Novel SME |
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.