Manufacturer registered with FDA
Chemoment Materials Co.,ltd
Hefei, China. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 12022–2022
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Chemoment Materials Co.,ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Chemoment Materials Co.,ltd | 1 clearances | 2022–2022 | Below |
| European Union | EUDAMED | Manufacturer | Chemoment Materials Co.,ltd | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Chemoment Materials Co.,Ltd | 1 | 2013–2013 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Chemoment Materials Co.,ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Impression tray | 2022 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Silicone Impression Material/ VPS Impression Material | 2025 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | Dental Impression Material | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CHEMOMENT MATERIALS CO.,LTDFDA reg. 3013020540 | Hefei Anhui, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086190). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.