Data / Medical devices / China / Sino-Dentex Co.,ltd
Sino-Dentex Co.,ltd: FDA-registered device maker in Changchun Jilin, China, 2 510(k) clearances
Sino-Dentex Co.,ltd is registered with the FDA (registration 3018283083) in Changchun Jilin, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 22, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018283083
- Address
- 721 Chenggong Road High-Tech Development District, Changchun Jilin, China, 130000
- Owner or operator
- SINO-DENTEX CO.,LTD (10083627)
- Roles
- Manufacturer
- First device listed
- December 7, 2021
- Registered through
- 2026
- Brand names listed
- Apoller
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 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 |
|---|---|---|---|---|---|---|
| September 22, 2023 | K232978 | DX. Bond V Dental Bonding Adhesive | KLE | Substantially Equivalent | Sino-Dentex Co., Ltd. | accessdata.fda.gov |
| November 14, 2018 | K180463 | Apoller Flow Light Cure Flowable Composite | EBF | Substantially Equivalent | Greenway Yw, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 22, 2023. 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.