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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 W.
Laval,  CA H7V 5B7
Applicant Contact LOUIS-PAUL MARIN
Correspondent
Itena Clinical
500 Boul Cartier W.
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
Predetermined Change
Control Plan Authorized		 No
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