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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cement, dental
510(k) Number K122549
Device Name DENTO TEMP
Original Applicant
500 boul cartier west
laval,  CA h7v 5b7
Original Contact louis-paul marin
Regulation Number872.3275
Classification Product Code
Date Received08/21/2012
Decision Date 04/26/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No