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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powder, porcelain
510(k) Number K121980
Device Name ZIRPRIME
Original Applicant
700 12th st sw
suite 100
washington,  DC  20005
Original Contact ivan wasserman
Regulation Number872.6660
Classification Product Code
Date Received07/06/2012
Decision Date 10/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No