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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 the device name listed in this FDA 510(k) record. The listed applicant is Septodont. It received FDA 510(k) clearance on 2021-09-16 under 510(k) 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. The listed applicant is Septodont. The 510(k) number is K212283.

When did BioRoot Flow 0.5g, BioRoot Flow 2g receive FDA 510(k) clearance?

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

Who is the listed applicant for BioRoot Flow 0.5g, BioRoot Flow 2g?

The FDA 510(k) record lists Septodont as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04757753Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled TrialACTIVE_NOT_RECRUITINGNCT05536115Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry SocketCOMPLETED

Other records listing Septodont as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211799Biodentine XP 500, Biodentine XP 200K172839ENDOSOLV

Related Devices (Code: KIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr CorporationK251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom Co., Ltd.K251884One-Fil Putty InjectableMediclus Co., Ltd.

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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