FDA.reportPublic FDA data

DURR DENTAL SE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30155096193015509619DURR DENTAL SE1N2026-01-01Hopfigheimer Str. 17 Bietigheim-Bissingen Baden-Wurttemberg DE 74321

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2321861965549497K250947VistaSoft 4.0 and VisionX 4.0QIH2025-08-27
2321861354635035K232487Provecta 3D Prime and Provecta 3D Prime CephOAS2023-09-14
2321861974821277K230095ScanX Swift 2.0, ScanX Swift View 2.0MUH2023-02-06
2321861950032879K213326VisionX 3.0LLZ2021-11-02
2321861722272309K203116SensorXMUH2021-03-19
2321861352186237K202633ScanX EdgeMUH2020-10-07
2321861732176921K193139ProVecta 3D Prime CephOAS2020-03-05
2321861639997400K192743VisionX 2.4LLZ2019-10-31
2321861272912561K190629DBSWIN and VISTAEASY Imaging SoftwareLLZ2019-04-01
2321862000747398K181432ProVectra 3D Prime with VistaSoftOAS2018-08-02
2321862007509825K172007CamX Triton HD Proxi HeadNTK2017-11-22
2321861036642349K170733ScanX Intraoral ViewMUH2017-05-01
2321861937370348K161444DBSWIN and VistaEasy Imaging SoftwareLLZ2016-06-21
2321861658427345K150672VistaCam iX ProofNBL2016-01-27
2321861603785734
2321861428426930
2321861602549140
2321861785018574
2321861883091085

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MUH42023-02-06
LLZ42021-11-02
OAS32023-09-14
QIH12025-08-27
NTK12017-11-22
NBL12016-01-27

PMN#

GUDID#

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