Durr Dental SE is one of 234 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Durr Dental SE - FDA 510(k) Cleared Devices
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
Durr Dental SE has 9 FDA 510(k) cleared medical devices. Based in Bietigheim-Bissingen, DE.
Latest FDA clearance: Aug 2025. Active since 2018. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Durr Dental SE Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Kamm & Associates and Kamm & Assosciates.
FDA 510(k) Regulatory Record - Durr Dental SE
9 devices
Cleared
Aug 27, 2025
VistaSoft 4.0 and VisionX 4.0
Radiology
152d
Cleared
Sep 14, 2023
Provecta 3D Prime and Provecta 3D Prime Ceph
Radiology
28d
Cleared
Feb 06, 2023
ScanX Swift 2.0, ScanX Swift View 2.0
Radiology
25d
Cleared
Nov 02, 2021
VisionX 3.0
Radiology
28d
Cleared
Mar 19, 2021
SensorX
Radiology
154d
Cleared
Mar 05, 2020
ProVecta 3D Prime Ceph
Radiology
113d
Cleared
Oct 31, 2019
VisionX 2.4
Radiology
31d
Cleared
Apr 01, 2019
DBSWIN and VISTAEASY Imaging Software
Radiology
20d
Cleared
Aug 02, 2018
ProVectra 3D Prime with VistaSoft
Radiology
62d