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FDA 510(k)

VENUS Bracket, ROSE Bracket

K-Number: K201410 · 2021-03-12

ApplicantGni Co., Ltd.
Decision Date2021-03-12
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VENUS Bracket, ROSE Bracket is the device name listed in this FDA 510(k) record. The listed applicant is Gni Co., Ltd.. It received FDA 510(k) clearance on 2021-03-12 under 510(k) number K201410. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENUS Bracket, ROSE Bracket?

VENUS Bracket, ROSE Bracket is a medical device that received FDA 510(k) clearance on 2021-03-12. The listed applicant is Gni Co., Ltd.. The 510(k) number is K201410.

When did VENUS Bracket, ROSE Bracket receive FDA 510(k) clearance?

VENUS Bracket, ROSE Bracket received FDA 510(k) clearance on 2021-03-12, under 510(k) number K201410.

Who is the listed applicant for VENUS Bracket, ROSE Bracket?

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

What is the FDA product code for VENUS Bracket, ROSE Bracket?

The FDA product code for VENUS Bracket, ROSE Bracket is NJM.

Other records listing Gni Co., Ltd. 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.

K191041Orthodontic Fixation Screw [Smart Anchor Miniscrew]K182672ROSA Bracket

Related Devices (Code: NJM)

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.

K232827LightForce Orthodontic SystemLightforce OrthodonticsK232011CleoAmerican OrthodonticsK231635A-Line AdvancedBiocetec Co., Ltd.K230225DynaFlex Clear Brackets & ButtonsDyna FlexK222847Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos MedicosK222764LightForce Orthodontic SystemLightforce Orthodontics

Official Source

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

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