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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 K121685
Original Applicant
124 gaither drive
suite 140
mt. laurel,  NJ  08054
Original Contact rick rosati
Regulation Number872.1745
Classification Product Code
Subsequent Product Code
Date Received06/07/2012
Decision Date 03/12/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No