Manufacturer registered with FDA
Hunan Ceramaster Material Technology Co., Ltd.
Changsha, China. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 12024–2024
- Markets registered in
- 44 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Hunan Ceramaster Material Technology 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 | Hunan Ceramaster Material Technology Co., Ltd. | 1 clearances | 2024–2024 | Below |
| Brazil | ANVISA | Manufacturer | HUNAN CERAMASTER MATERIAL TECHNOLOGY CO., LTD. | 2 | 2024–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | HUNAN CERAMASTER MATERIAL TECHNOLOGY CO., LTD | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | HUNAN CERAMASTER MATERIAL TECHNOLOGY CO.,LTD | 1 | — | 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 Hunan Ceramaster Material Technology 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Dental Zirconia Blank | 2024 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Maker | Firing Paste | 2025 |
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 |
|---|---|---|
| HUNAN CERAMASTER MATERIAL TECHNOLOGY CO., LTDFDA reg. 3031606428 | Changsha Hunan, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090889). 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.