Manufacturer registered with FDA
Frank Dental GmbH
Gmund, Germany. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 719 registrations outside the US
- Establishments
- 1Germany
Registered in 7 markets
Where regulators' registries name Frank 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 | Frank Dental GmbH | 2 device types | — | Below |
| Brazil | ANVISA | Manufacturer | Frank Dental GMBH | 7 | 2015–2019 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Frank DentalFrank Dental GmbH | 4 | 2010–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | Frank Dental GmbH | 2 | 2012–2012 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Frank Dental GmbH | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | FRANK DENTAL GMBH | 2 | 2011–2021 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Frank Dental GmbH | 2 | — | 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 Frank 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 |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | — | 2009 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | — | 2009 |
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 |
|---|---|---|
| FRANK DENTAL GMBHFDA reg. 3006765435 | Gmund Bavaria, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10030439). 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.