BIO-C REPAIR

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.

Pre-market Notification Details

Device IDK180185
510k NumberK180185
Device Name:BIO-C REPAIR
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 Oliveria
CorrespondentJuliana Norder
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 Received2018-01-23
Decision Date2018-08-31
Summary:summary

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