FDA 510(k) Application Details - K123276

Device Classification Name Resin, Root Canal Filling

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510(K) Number K123276
Device Name Resin, Root Canal Filling
Applicant MICRO-MEGA SOCIETE ANONYME
5-12 RUE DU TUNNEL
CEDEX BESANCON 25006 FR
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Contact PHILIPPE CONCHE
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Regulation Number 872.3820

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Classification Product Code KIF
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Date Received 10/19/2012
Decision Date 03/10/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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