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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K122522
Device Name DENTOETCH QUICKBOND BOND ACTIVATOR
Applicant
ITENA CLINICAL
500 BOUL CARTIER WEST
LAVAL,  CA H7V 5B7
Applicant Contact LOUIS-PAUL MARIN
Correspondent
ITENA CLINICAL
500 BOUL CARTIER WEST
LAVAL,  CA H7V 5B7
Correspondent Contact LOUIS-PAUL MARIN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received08/20/2012
Decision Date 03/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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