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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, operative dental
510(k) Number K120239
Device Name ELEVANCE
Original Applicant
1801 edgecliff drive
fullerton,  CA  92831
Original Contact robyn scopis
Regulation Number872.6640
Classification Product Code
Date Received01/26/2012
Decision Date 08/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No