Durr Dental SE
Bietigheim-Bissingen Baden-Wurttemberg, DE
DURR DENTAL SE appears in FDA device records in Bietigheim-Bissingen Baden-Wurttemberg, DE. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Durr Dental SE between 2018 and 2025. The busiest year on record is 2020, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 3 |
| 2021 | 2 |
| 2023 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250947 | VistaSoft 4.0 and VisionX 4.0 | QIH | Substantially Equivalent | |
| K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph | OAS | Substantially Equivalent | |
| K230095 | ScanX Swift 2.0, ScanX Swift View 2.0 | MUH | Substantially Equivalent | |
| K213326 | VisionX 3.0 | LLZ | Substantially Equivalent | |
| K203116 | SensorX | MUH | Substantially Equivalent | |
| K203287 | DBSWIN, VISTAEASY | LLZ | Substantially Equivalent | |
| K202633 | ScanX Edge | MUH | Substantially Equivalent | |
| K193139 | ProVecta 3D Prime Ceph | OAS | Substantially Equivalent | |
| K192743 | VisionX 2.4 | LLZ | Substantially Equivalent | |
| K190629 | DBSWIN and VISTAEASY Imaging Software | LLZ | Substantially Equivalent | |
| K181432 | ProVectra 3D Prime with VistaSoft | OAS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015509619 | 3015509619 | DURR DENTAL SE | Hopfigheimer Str. 17, Bietigheim-Bissingen Baden-Wurttemberg 74321 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QIHAutomated Radiological Image Processing Software
- EHZEvacuator, Oral Cavity
- IWZFilm, Radiographic
- EGZHolder, Film, X-Ray
- NTKLight Transmission Caries Detector
- NBLLight-Induced Fluorescence Caries Detector
- LLZSystem, Image Processing, Radiological
- MUHSystem, X-Ray, Extraoral Source, Digital
- NRDUnit, Operative Dental, Accessories
- OASX-Ray, Tomography, Computed, Dental
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain