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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 K112139
Device Name THE CANARY SYSTEM
Applicant
Quantum Dental Technologies, Inc.
748 Briar Hill Ave.
Toronto,  CA M6B 1L3
Applicant Contact JOSH SILVERTOWN
Correspondent
Quantum Dental Technologies, Inc.
748 Briar Hill Ave.
Toronto,  CA M6B 1L3
Correspondent Contact JOSH SILVERTOWN
Regulation Number872.1745
Classification Product Code
NBL  
Date Received07/26/2011
Decision Date 10/26/2012
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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