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FDA 510(k)

ORTHODONTIC CERAMIC BRACKET

K-Number: K090567 · 2009-05-27

ApplicantStar Dentech Korea., Corp
Decision Date2009-05-27
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC CERAMIC BRACKET is the device name listed in this FDA 510(k) record. The listed applicant is Star Dentech Korea., Corp. It received FDA 510(k) clearance on 2009-05-27 under 510(k) number K090567. 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 ORTHODONTIC CERAMIC BRACKET?

ORTHODONTIC CERAMIC BRACKET is a medical device that received FDA 510(k) clearance on 2009-05-27. The listed applicant is Star Dentech Korea., Corp. The 510(k) number is K090567.

When did ORTHODONTIC CERAMIC BRACKET receive FDA 510(k) clearance?

ORTHODONTIC CERAMIC BRACKET received FDA 510(k) clearance on 2009-05-27, under 510(k) number K090567.

Who is the listed applicant for ORTHODONTIC CERAMIC BRACKET?

The FDA 510(k) record lists Star Dentech Korea., Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHODONTIC CERAMIC BRACKET?

The FDA product code for ORTHODONTIC CERAMIC BRACKET is NJM.

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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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