Manufacturer registered with FDA
Adentatec GmbH
Woerth am Main, Germany. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 611 registrations outside the US
- Establishments
- 1Germany
Registered in 6 markets
Where regulators' registries name Adentatec 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 | Adentatec GmbH | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Adentatec GmbH | 4 | 2008–2009 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ADENTATEC GMBH | 3 | 2011–2012 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Adentatec GmbH | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 阿登特克有限公司Adentatec GmbH | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Adentatec GmbH | 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 Adentatec 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 | System DuroSystem KNSystem MGSystem NESystem NHSystem SINSystem SoftSystem Soft BlankSystem Ti5-Blank | 2013 |
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 |
|---|---|---|
| Adentatec GmbHFDA reg. 3010605319 | Woerth am Main Bavaria, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045442). 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.