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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Transmission Caries Detector
510(k) Number K172007
Device Name CamX Triton HD Proxi Head
Applicant
Duerr Dental AG
Hopfigheimer Strasse 17
Bietigheim-Bissingen,  DE D-74321
Applicant Contact Oliver Lange
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number872.1745
Classification Product Code
NTK  
Date Received07/03/2017
Decision Date 11/22/2017
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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