Bio-C Repair Ion+

Resin, Root Canal Filling

Angelus Industria De Produtos Odontologicos S/A

The following data is part of a premarket notification filed by Angelus Industria De Produtos Odontologicos S/a with the FDA for Bio-c Repair Ion+.

Pre-market Notification Details

Device IDK201222
510k NumberK201222
Device Name:Bio-C Repair Ion+
ClassificationResin, Root Canal Filling
Applicant Angelus Industria De Produtos Odontologicos S/A Rua Waldir Landgraf, 101 Londrina,  BR 86.031-218
ContactPaulo Sergio Calixto De Oliveira
CorrespondentJuliana Norder Trostdorf
Angelus Industria De Produtos Odontologicos S/A Rua Waldir Landgraf, 101 Londrina,  BR 86.031-218
Product CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-06
Decision Date2021-02-11

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