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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name resin, root canal filling
510(k) Number K112078
Device Name ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
Original Applicant
MARUCHI
951 starbuck st. unit j
fullerton,  CA  92833
Original Contact priscilla chung
Regulation Number872.3820
Classification Product Code
KIF  
Date Received07/21/2011
Decision Date 03/19/2012
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
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