Data / Medical devices / China / Chemoment Materials Co.,ltd
Chemoment Materials Co.,ltd: FDA-registered device maker in Hefei Anhui, China, 1 510(k) clearance
Chemoment Materials Co.,ltd is registered with the FDA (registration 3013020540) in Hefei Anhui, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 8, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013020540
- Address
- No., Renhe Industry Town, Shuangfeng Economic Development Zone, Hefei Anhui, China, 230081
- Owner or operator
- Chemoment Materials Co.,ltd (10086190)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 21, 2022
- Registered through
- 2026
- Brand names listed
- Dental Impression Material, Impression tray, Silicone Impression Material/ VPS Impression Material
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Material, Impression | ELW | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| August 8, 2022 | K221668 | Dental Impression Material | ELW | Substantially Equivalent | Chemoment Materials Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Impression
- All makers of Tray, Impression, Preformed
- All makers of Syringe, Restorative And Impression Material
Updated August 8, 2022. 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.