BioRoot Flow 0.5g, BioRoot Flow 2g

Resin, Root Canal Filling


The following data is part of a premarket notification filed by Septodont with the FDA for Bioroot Flow 0.5g, Bioroot Flow 2g.

Pre-market Notification Details

Device IDK212283
510k NumberK212283
Device Name:BioRoot Flow 0.5g, BioRoot Flow 2g
ClassificationResin, Root Canal Filling
Applicant Septodont 58, Rue Du Pont De Creteil Saint-maur Des Fosses Cedex,  FR 94107
ContactKimty Bui Van
CorrespondentGreg Montgomery
Septodont 205 Granite Run Drive, Suite 150 Lancaster,  PA  17601
Product CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-21
Decision Date2021-09-16

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