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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
Applicant
PAXMED INTERNATIONAL
11234 EL CAMINO
SUITE 200
san diego,  CA  92130
Applicant Contact allison komiyama
Correspondent
PAXMED INTERNATIONAL
11234 EL CAMINO
SUITE 200
san diego,  CA  92130
Correspondent 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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