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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light-Induced Fluorescence Caries Detector
510(k) Number K040063
Device Name INSPEKTOR PRO
Applicant
Inspektor Dental Care BV
Quellinjnstraat 92
Amsterdam,  NL 1072 XX
Applicant Contact ELBERT WALLER
Correspondent
Inspektor Dental Care BV
Quellinjnstraat 92
Amsterdam,  NL 1072 XX
Correspondent Contact ELBERT WALLER
Regulation Number872.1745
Classification Product Code
NBL  
Date Received01/13/2004
Decision Date 06/24/2004
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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