Data / Medical devices / Germany / Durr Dental Se
Durr Dental Se: FDA-registered device maker in Bietigheim-Bissingen Baden-Wurttemberg, Germany, 12 510(k) clearances
Durr Dental Se is registered with the FDA (registration 3015509619) in Bietigheim-Bissingen Baden-Wurttemberg, Germany. It lists 11 device types. The FDA files 12 510(k) clearances under its listings, the newest dated September 17, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015509619
- Address
- Hopfigheimer Str. 17, Bietigheim-Bissingen Baden-Wurttemberg, Germany, 74321
- Owner or operator
- DURR DENTAL SE (10047925)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 17, 2014
- Registered through
- 2027
- Brand names listed
- Adapter 11 to 16mm for HVE Air Protect XL, XL Plus, Adapter 16-11, CamX Elara, CamX Spectra, CamX Triton HD Cam, CamX Triton HD Handpiece, CamX Triton HD Proxi, CamX Triton HD Spectra and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Dental Barriers And Sleeves | PEM | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Film, Radiographic | IWZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Light Transmission Caries Detector | NTK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Light-Induced Fluorescence Caries Detector | NBL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 17, 2026 | K262073 | Hygienic Protective Bite Cover (2207-010-50) | PEM | Substantially Equivalent | Dürr Dental SE | accessdata.fda.gov |
| August 27, 2025 | K250947 | VistaSoft 4.0 and VisionX 4.0 | QIH | Substantially Equivalent | Durr Dental SE | accessdata.fda.gov |
| September 14, 2023 | K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph | OAS | Substantially Equivalent | Durr Dental SE | accessdata.fda.gov |
| February 6, 2023 | K230095 | ScanX Swift 2.0, ScanX Swift View 2.0 | MUH | Substantially Equivalent | Durr Dental SE | accessdata.fda.gov |
| November 2, 2021 | K213326 | VisionX 3.0 | LLZ | Substantially Equivalent | Durr Dental SE | accessdata.fda.gov |
| March 19, 2021 | K203116 | SensorX | MUH | Substantially Equivalent | Durr Dental SE | accessdata.fda.gov |
| October 7, 2020 | K202633 | ScanX Edge | MUH | Substantially Equivalent | Dürr Dental SE | accessdata.fda.gov |
| March 5, 2020 | K193139 | ProVecta 3D Prime Ceph | OAS | Substantially Equivalent | Durr Dental SE | accessdata.fda.gov |
| August 2, 2018 | K181432 | ProVectra 3D Prime with VistaSoft | OAS | Substantially Equivalent | Durr Dental SE | accessdata.fda.gov |
| November 22, 2017 | K172007 | CamX Triton HD Proxi Head | NTK | Substantially Equivalent | Duerr Dental AG | accessdata.fda.gov |
| May 1, 2017 | K170733 | ScanX Intraoral View | MUH | Substantially Equivalent | Duerr Dental AG | accessdata.fda.gov |
| January 27, 2016 | K150672 | VistaCam iX Proof | NBL | Substantially Equivalent | Durr Dental AG | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of Evacuator, Oral Cavity
- All makers of System, Image Processing, Radiological
- All makers of Holder, Film, X-Ray
- All makers of Light Transmission Caries Detector
- All makers of Unit, Operative Dental, Accessories
Updated September 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.