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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 K113568
Device Name MTA-FILLAPEX
Original Applicant
PAXMED INTERNATIONAL
11234 el camino
suite 200
san diego,  CA  92130
Original Contact allison komiyama
Regulation Number872.3820
Classification Product Code
KIF  
Date Received12/02/2011
Decision Date 08/21/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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