Cleared Traditional

BioRoot Flow 0.5g, BioRoot Flow 2g (K212283) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K212283 is an FDA 510(k) clearance for the BioRoot Flow 0.5g, BioRoot Flow 2g. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Septodont (Saint-Maur Des Fosses Cedex, FR). The FDA issued a Cleared decision on September 16, 2021 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Septodont devices

Submission Details

510(k) Number K212283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 127d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KIF Resin, Root Canal Filling

All 58
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K212283.
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K212563 · Prevest Denpro Limited · May 2022
Injectable Root Canal Bioceramic Sealer
K212983 · Beijing C-Root Dental Medical Devices Co., Ltd. · Dec 2021
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Sonendo Filling Material 5C
K211995 · Sonendo, Inc. · Aug 2021
White Endoseal MTA
K212229 · Maruchi · Aug 2021
Biodentine XP 500, Biodentine XP 200
K211799 · Septodont · Aug 2021