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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 K140247
Device Name MTA FILLAPEX
Applicant
Angelus Industria DE Productos Odontologicos SA
18851 NE 29th Ave.
720
Aventura,  FL  33180
Applicant Contact TARA CONRAD
Correspondent
Angelus Industria DE Productos Odontologicos SA
18851 NE 29th Ave.
720
Aventura,  FL  33180
Correspondent Contact TARA CONRAD
Regulation Number872.3820
Classification Product Code
KIF  
Date Received01/30/2014
Decision Date 04/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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