BioRoot Flow 0.5g, BioRoot Flow 2g— 510(k) K212283

Substantially Equivalent

Septodont

FDA 510(k) clearance K212283 for BioRoot Flow 0.5g, BioRoot Flow 2g, Substantially Equivalent on 2021-09-16. Applicant: Septodont. Device class: 2.

Clearance details

Applicant: Septodont
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2021-07-21
Decision date: 2021-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint-Maur Des Fosses Cedex, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.