Manufacturer registered with FDA
Shandong Meda New Materials Co.,LTD
Linyi, China. Lists 1 dental device type with FDA across 0 registered establishments.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 32 registrations outside the US
- Establishments
- 0—
Registered in 3 markets
Where regulators' registries name Shandong Meda New 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 | Shandong Meda New Materials Co.,LTD | 1 device types | — | Below |
| Brazil | ANVISA | Manufacturer | SHANDONG MEDA NEW MATERIALS CO., LTD | 1 | 2026–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Shandong Meda New Materials 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 Shandong Meda New 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 |
|---|---|---|---|---|
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | Dental selective laser melting Cobalt-based alloy powderDental Selective Laser Melting Titanium Alloy Powder | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095836). 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.