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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 K190537
Device Name BIO-C Sealer Ion+
Applicant
Angelus Industria de Produtos Odontologicos S/A
Rua Waldir Landgraf, 101
Londrina,  BR 86.031-218
Applicant Contact Paulo Sergio Calixto De Oliveira
Correspondent
Angelus Industria de Produtos Odontologicos S/A
Rua Waldir Landgraf, 101
Londrina,  BR 86.031-218
Correspondent Contact Juliana Norder Trostdorf
Regulation Number872.3820
Classification Product Code
KIF  
Date Received03/04/2019
Decision Date 12/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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