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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 K112118
Original Applicant
1100 west irving park rd.
schaumburg,  IL  60193
Original Contact michelle schiltz-taing
Regulation Number872.3200
Classification Product Code
Date Received07/25/2011
Decision Date 11/17/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No