BIO-C SEALER

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 Sealer.

Pre-market Notification Details

Device IDK172701
510k NumberK172701
Device Name:BIO-C SEALER
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
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 Received2017-09-07
Decision Date2018-01-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00366975012210 K172701 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.