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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Fluorescence Caries Detection
510(k) Number K150672
Device Name VistaCam iX Proof
Applicant
Durr Dental AG
Hopfigheimer Strasse 17
Bietigheim-Bissingen,  DE D-74321
Applicant Contact Oliver Lange
Correspondent
AIR TECHNIQUES, INC.
1295 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact Pablo Martinez
Regulation Number872.1745
Classification Product Code
NBL  
Date Received03/16/2015
Decision Date 01/27/2016
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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