DEXIS CariVu 3-in-1 By KaVo

Caries Detector, Laser Light, Transmission

Kaltenbach & Voigt GmbH

The following data is part of a premarket notification filed by Kaltenbach & Voigt Gmbh with the FDA for Dexis Carivu 3-in-1 By Kavo.

Pre-market Notification Details

Device IDK182712
501k NumberK182712
Device Name:DEXIS CariVu 3-in-1 By KaVo
ClassificationCaries Detector, Laser Light, Transmission
Applicant Kaltenbach & Voigt GmbH Bismarckring 39 Biberach,  DE 88440
ContactStefan Trampler
CorrespondentFrank Ray
KaVo Dental Technologies, LLC 11727 Fruehauf Drive Charlotte,  NC  28273
Product CodeNTK  
CFR Regulation Number872.1745 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-27
Decision Date2019-11-23

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