ProVecta 3D Prime Ceph

X-ray, Tomography, Computed, Dental

Durr Dental SE

The following data is part of a premarket notification filed by Durr Dental Se with the FDA for Provecta 3d Prime Ceph.

Pre-market Notification Details

Device IDK193139
510k NumberK193139
Device Name:ProVecta 3D Prime Ceph
ClassificationX-ray, Tomography, Computed, Dental
Applicant Durr Dental SE Hopfigheimer Str. 17 Bietigheim-bissingen,  DE 74321
ContactOliver Lange
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeOAS  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-13
Decision Date2020-03-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E2472210200729 K193139 000

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