Manufacturer registered with FDA
SAM Präzisionstechnik GmbH
Gauting, Germany. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 312 registrations outside the US
- Establishments
- 1Germany
Registered in 3 markets
Where regulators' registries name SAM Präzisionstechnik 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 | SAM Präzisionstechnik GmbH | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | SAM Präzisionstechnik GmbH | 6 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Sam Prazisionstechnik GmbHSAM Prazisionstechnik GmbH | 6 | 1998–2001 | 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 SAM Präzisionstechnik 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 |
|---|---|---|---|---|
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | axiosnapmount | 2002 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | axioprisaSAM | 2002 |
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 |
|---|---|---|
| SAM PRAZISIONSTECHNIK GMBHFDA reg. 3001685118 | Gauting Bavaria, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9052202). 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.