Cleared Traditional

BioRoot Flow 0.5g, BioRoot Flow 2g

K212283 · Septodont · Dental
Sep 2021
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K212283 is an FDA 510(k) clearance for the BioRoot Flow 0.5g, BioRoot Flow 2g, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Septodont (Saint-Maur Des Fosses Cedex, FR). The FDA issued a Cleared decision on September 16, 2021, 57 days after receiving the submission on July 21, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K212283 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2021
Decision Date September 16, 2021
Days to Decision 57 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820