Manufacturer registered with FDA
Dr. Walser Dental GmbH
RADOLFZELL, Germany. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 46 registrations outside the US
- Establishments
- 1Germany
Registered in 4 markets
Where regulators' registries name Dr. Walser Dental GmbH 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 | Dr. Walser Dental GmbH | 2 device types | — | Below |
| South Korea | MFDS | Manufacturer | Dr. Walser Dental GmbH | 3 | 2008–2015 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DR. WALSER DENTAL GMBH | 2 | 2006–2012 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DR. WALSER DENTAL GMBH | 1 | 2022–2022 | 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 Dr. Walser Dental GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | WALSER MATRIX | 1981 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | MPI TRAY | 1981 |
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 |
|---|---|---|
| DR. WALSER DENTAL G.M.B.H.FDA reg. 8010584 | RADOLFZELL Baden-Wurttemberg, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010584). 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.