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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 K201222
Device Name Bio-C Repair Ion+
Applicant
Angelus Industria DE Produtos Odontologicos S/A
Rua Waldir Landgraf, 101
Londrina,  BR 86031-218
Applicant Contact Paulo Sergio Calixto de Oliveira
Correspondent
Angelus Industria DE Produtos Odontologicos S/A
Rua Waldir Landgraf, 101
Londrina,  BR 86031-218
Correspondent Contact Juliana Norder Trostdorf
Regulation Number872.3820
Classification Product Code
KIF  
Date Received05/06/2020
Decision Date 02/11/2021
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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