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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 K123402
Device Name DIAGNOCAM
Applicant
KALTENBACH & VOIGT GMBH
BISMARCHRING 39
BIBERACH / RISS,  DE 88400
Applicant Contact STEFAN TRAMPLER
Correspondent
KALTENBACH & VOIGT GMBH
BISMARCHRING 39
BIBERACH / RISS,  DE 88400
Correspondent Contact STEFAN TRAMPLER
Regulation Number872.1745
Classification Product Code
NTK  
Date Received11/05/2012
Decision Date 09/24/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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