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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name caries detector, laser light, transmission
510(k) Number K182712
Device Name DEXIS CariVu 3-in-1 by KaVo
Kaltenbach & Voigt GmbH
Bismarckring 39
Biberach,  DE 88440
Applicant Contact Stefan Trampler
KaVo Dental Technologies, LLC
11727 Fruehauf Drive
Charlotte,  NC  28273
Correspondent Contact Frank Ray
Regulation Number872.1745
Classification Product Code
Subsequent Product Code
Date Received09/27/2018
Decision Date 11/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No