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FDA 510(k)

BioRoot Flow 0.5g, BioRoot Flow 2g

K-Number: K212283 · 2021-09-16

ApplicantSeptodont
Decision Date2021-09-16
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BioRoot Flow 0.5g, BioRoot Flow 2g is a medical device manufactured by Septodont. It received FDA 510(k) clearance on 2021-09-16 under approval number K212283. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioRoot Flow 0.5g, BioRoot Flow 2g?

BioRoot Flow 0.5g, BioRoot Flow 2g is a medical device that received FDA 510(k) clearance on 2021-09-16. It is manufactured by Septodont. The 510(k) number is K212283.

When was BioRoot Flow 0.5g, BioRoot Flow 2g approved by the FDA?

BioRoot Flow 0.5g, BioRoot Flow 2g received FDA 510(k) clearance on 2021-09-16, under approval number K212283.

What company makes BioRoot Flow 0.5g, BioRoot Flow 2g?

BioRoot Flow 0.5g, BioRoot Flow 2g is manufactured by Septodont.

What is the FDA product code for BioRoot Flow 0.5g, BioRoot Flow 2g?

The FDA product code for BioRoot Flow 0.5g, BioRoot Flow 2g is KIF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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