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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)
Applicant
Maruchi
951 St.Arbuck St.
Unit J
Fullerton,  CA  92833
Applicant Contact Priscilla Chung
Correspondent
Maruchi
951 St.Arbuck St.
Unit J
Fullerton,  CA  92833
Correspondent Contact Priscilla Chung
Regulation Number872.3820
Classification Product Code
KIF  
Date Received07/21/2011
Decision Date 03/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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