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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 K123276
Device Name MM-SEAL
Applicant
Micro-Mega Societe Anonyme
5-12 Rue Du Tunnel
Besancon,  FR 25006
Applicant Contact PHILIPPE CONCHE
Correspondent
Micro-Mega Societe Anonyme
5-12 Rue Du Tunnel
Besancon,  FR 25006
Correspondent Contact PHILIPPE CONCHE
Regulation Number872.3820
Classification Product Code
KIF  
Date Received10/19/2012
Decision Date 03/10/2014
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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