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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 DEUTOETCH QUICKBOND BOND ACTIRATOR
Original Applicant
ITENA CLINICAL
500 boul cartier west
laval,  CA h7v 5b7
Original 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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