VisionX 2.4

System, Image Processing, Radiological

Durr Dental SE

The following data is part of a premarket notification filed by Durr Dental Se with the FDA for Visionx 2.4.

Pre-market Notification Details

Device IDK192743
510k NumberK192743
Device Name:VisionX 2.4
ClassificationSystem, Image Processing, Radiological
Applicant Durr Dental SE Hopfigheimer Str. 17 Bietigheim-bissingen,  DE 74321
ContactOliver Lange
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2019-10-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E247E7300 K192743 000

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