Manufacturer registered with FDA
Durr Dental SE
Bietigheim-Bissingen, Germany. Lists 7 dental device types with FDA across 2 registered establishments, and holds 6 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 33
- 510(k) clearances
- 62018–2023
- Markets registered in
- 15229 registrations outside the US
- Establishments
- 2Germany
510(k) clearances per year, 2007–2026
Registered in 15 markets
Where regulators' registries name Durr Dental SE 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 | Durr Dental SE | 6 clearances | 2018–2023 | Below |
| Saudi Arabia | SFDA | Manufacturer | DURR DENTAL SE | 65 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | DURR DENTAL SE | 57 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Durr Dental SE | 20 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Durr Dental SE | 16 | 2018–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | DURR DENTAL SEDURR DENTAL SE. | 14 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DURR DENTAL SEDÜRR DENTAL SE · Durr Dental SE | 14 | 2013–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Durr Optronik GmbH & Co.KGDURR DENTAL SE · Durr Dental SE | 13 | 2008–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | Durr Dental SEDURR DENTAL SE | 11 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DÜRR DENTAL SE | 5 | 2014–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DURR DENTAL SE | 4 | 2020–2024 | Pure Global AI |
| Canada | Health Canada | Registration holder | DURR DENTAL SE | 3 | 2023–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | DÜRR DENTAL SE | 3 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Dürr Dental SE | 3 | 2024–2024 | Pure Global AI |
| China | NMPA | Registration holder | 德国迪珥齿科股份公司DüRR DENTAL SE | 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 Durr Dental SE currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | ScanX Classic ViewScanX EdgeScanX Intraoral ViewScanX Swift 2ScanX Swift ViewScanX Swift View 2SensorX Size #1SensorX Size #2 | 2017 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | ProVecta 3D PrimeProVecta 3D Prime CephProVecta 3D Prime with VisionX | 2018 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | VistaPosition AnteriorVistaPosition BitewingVistaPosition EndoVistaPosition Posterior | 2019 |
| Light-Induced Fluorescence Caries DetectorNBL · Class 2 | Caries detection devices | Maker | CamX SpectraCamX Triton HD Spectra | 2016 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | CamX ElaraCamX Triton HD CamCamX Triton HD HandpieceMojave MobileMojave Mobile with Amalgam SeparatorVS 250 S (VacStar Viper) | 2014 |
| Light Transmission Caries DetectorNTK · Class 2 | Caries detection devices | Maker | CamX Triton HD Proxi | 2017 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Adapter 11 to 16mm for HVE Air Protect XL, XL PlusAdapter 16-11HVE Air Protect XL Plus, grayHVE Air Protect XL, grayHVE Y-Adapter (11 to 16mm for HVE Air Protect XL Plus)Prophylaxis Cannula, d=16 mm, greyUniversal Cannula Protect, d=16 mm, greyUniversal Cannula, d=16 mm, greyY-Adapter Set | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Durr Dental SE as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Sep 2023 | K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph | OAS Dental Computed Tomography X-Ray |
| 6 Feb 2023 | K230095 | ScanX Swift 2.0, ScanX Swift View 2.0 | MUH Digital Extraoral Source X-Ray System |
| 19 Mar 2021 | K203116 | SensorX | MUH Digital Extraoral Source X-Ray System |
| 7 Oct 2020 | K202633 | ScanX Edge | MUH Digital Extraoral Source X-Ray System |
| 5 Mar 2020 | K193139 | ProVecta 3D Prime Ceph | OAS Dental Computed Tomography X-Ray |
| 2 Aug 2018 | K181432 | ProVectra 3D Prime with VistaSoft | OAS Dental Computed Tomography X-Ray |
Also lists devices cleared under other names
Durr Dental SE lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Duerr Dental AG (2), Durr Dental AG (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Nov 2017 | K172007 | CamX Triton HD Proxi Head | Duerr Dental AG | NTK Light Transmission Caries Detector |
| 1 May 2017 | K170733 | ScanX Intraoral View | Duerr Dental AG | MUH Digital Extraoral Source X-Ray System |
| 27 Jan 2016 | K150672 | VistaCam iX Proof | Durr Dental AG | NBL Light-Induced Fluorescence Caries Detector |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DURR DENTAL SEFDA reg. 3015509619 | Bietigheim-Bissingen Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer |
| Durr Optronik GmbH & Co. KGFDA reg. 3001052305 | Gechingen Baden-Wurttemberg, Germany | Manufacturer |
Other names on FDA records
Durr Optronik GmbH & Co.KG
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047925). 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.