Manufacturer registered with FDA
Scheftner GmbH
Mainz, Germany. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 3195 registrations outside the US
- Establishments
- 1Germany
Registered in 3 markets
Where regulators' registries name Scheftner 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 | Scheftner GmbH | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Scheftner GmbH | 184 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | SCHEFTNER GMBH | 11 | 2023–2024 | 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 Scheftner 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 |
|---|---|---|---|---|
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | Fusion AMi-ProMeltModelStar SMogucera CMogucera NStarbond CoStarbond CoSStarbond EasyStarbond Ti4Starbond Ti5 1 moreTiplaDur23 | 2014 |
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 |
|---|---|---|
| SCHEFTNER GMBHFDA reg. 1000304307 | Mainz Rhineland-Palatinate, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048033). 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.