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FDA 510(k)

Ceramic Brackets Orthometric

K-Number: K222847 · 2023-05-04

ApplicantOrthometric - Industria E Comercio DE Produtos Medicos
Decision Date2023-05-04
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ceramic Brackets Orthometric is the device name listed in this FDA 510(k) record. The listed applicant is Orthometric - Industria E Comercio DE Produtos Medicos. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K222847. 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 Ceramic Brackets Orthometric?

Ceramic Brackets Orthometric is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Orthometric - Industria E Comercio DE Produtos Medicos. The 510(k) number is K222847.

When did Ceramic Brackets Orthometric receive FDA 510(k) clearance?

Ceramic Brackets Orthometric received FDA 510(k) clearance on 2023-05-04, under 510(k) number K222847.

Who is the listed applicant for Ceramic Brackets Orthometric?

The FDA 510(k) record lists Orthometric - Industria E Comercio DE Produtos Medicos as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ceramic Brackets Orthometric?

The FDA product code for Ceramic Brackets Orthometric is NJM.

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 FlexK222764LightForce Orthodontic SystemLightforce OrthodonticsK220689Vatech ClismileRayence 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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