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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name coating, filling material, resin
510(k) Number K021503
Original Applicant
1100 west irving park rd.
schaumburg,  IL  60193
Original Contact stephen (steve) smith
Regulation Number872.3310
Classification Product Code
Date Received05/09/2002
Decision Date 08/01/2002
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