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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 K180185
Device Name BIO-C REPAIR
Applicant
Angelus Industria DE Produtos Odontologicos S/A
Rua Waldir Landgraf, 101
Londrina,  BR 86031-218
Applicant Contact Paulo Sergio Calixto de Oliveria
Correspondent
Angelus Industria DE Produtos Odontologicos S/A
Rua Waldir Landgraf, 101
Londrina,  BR 86031-218
Correspondent Contact Juliana Norder
Regulation Number872.3820
Classification Product Code
KIF  
Date Received01/23/2018
Decision Date 08/31/2018
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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