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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
Predetermined Change
Control Plan Authorized		 No
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