Medical Device Manufacturer · DE , Bietigheim-Bissingen

Durr Dental SE - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2018

Recent clearances: VistaSoft 4.0 and VisionX 4.0, Provecta 3D Prime and Provecta 3D Prime Ceph, ScanX Swift 2.0, ScanX Swift View 2.0

9
Total
9
Cleared
0
Denied

FDA 510(k) Regulatory Record - Durr Dental SE Radiology ✕

9 devices
1-9 of 9
Cleared Aug 27, 2025
VistaSoft 4.0 and VisionX 4.0
K250947 · QIH
Radiology · 152d
Cleared Sep 14, 2023
Provecta 3D Prime and Provecta 3D Prime Ceph
K232487 · OAS
Radiology · 28d
Cleared Feb 06, 2023
ScanX Swift 2.0, ScanX Swift View 2.0
K230095 · MUH
Radiology · 25d
Cleared Nov 02, 2021
VisionX 3.0
K213326 · LLZ
Radiology · 28d
Cleared Mar 19, 2021
SensorX
K203116 · MUH
Radiology · 154d
Cleared Mar 05, 2020
ProVecta 3D Prime Ceph
K193139 · OAS
Radiology · 113d
Cleared Oct 31, 2019
VisionX 2.4
K192743 · LLZ
Radiology · 31d
Cleared Apr 01, 2019
DBSWIN and VISTAEASY Imaging Software
K190629 · LLZ
Radiology · 20d
Cleared Aug 02, 2018
ProVectra 3D Prime with VistaSoft
K181432 · OAS
Radiology · 62d
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