Not currently registered with FDA under this name
Durr Dental AG
Bietigheim-Bissingen, Germany. Named as applicant on 1 dental 510(k) clearance between 2016 and 2016. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12016–2016
- Markets registered in
- 945 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name Durr Dental AG as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Durr Dental AG | 1 clearances | 2016–2016 | Below |
| Taiwan | TFDA | Manufacturer | DURR DENTAL AG | 14 | 2006–2016 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Durr Dental AG | 13 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Durr Dental AGDurr Dental GmbH. · DURR DENTAL AG · +1 | 8 | 1998–2017 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | DURR DENTAL AG | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Durr Dental AG | 2 | 2013–2013 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DURR DENTAL AG | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Durr Dental AGDürr Dental AG | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DURR DENTAL AG. | 1 | 2014–2014 | 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
510(k) clearances
Clearances on which FDA names Durr Dental AG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Jan 2016 | K150672 | VistaCam iX Proof | NBL Light-Induced Fluorescence Caries Detector |
Some of these clearances are listed with FDA today by another company: Durr Dental SE (1).
Sources
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 of the most recent filing, which can be a US agent.