FDA 510(k)

Luce Ceramic Bracket

K-Number: K201038 · 2020-10-09

Decision Date2020-10-09

Product CodeNJM

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Luce Ceramic Bracket is the device name listed in this FDA 510(k) record. The listed applicant is Luce Castle Co., Ltd.. It received FDA 510(k) clearance on 2020-10-09 under 510(k) number K201038. 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 Luce Ceramic Bracket?

Luce Ceramic Bracket is a medical device that received FDA 510(k) clearance on 2020-10-09. The listed applicant is Luce Castle Co., Ltd.. The 510(k) number is K201038.

When did Luce Ceramic Bracket receive FDA 510(k) clearance?

Luce Ceramic Bracket received FDA 510(k) clearance on 2020-10-09, under 510(k) number K201038.

Who is the listed applicant for Luce Ceramic Bracket?

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

What is the FDA product code for Luce Ceramic Bracket?

The FDA product code for Luce Ceramic Bracket 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 Orthodontics K232011CleoAmerican Orthodontics K231635A-Line AdvancedBiocetec Co., Ltd.K230225DynaFlex Clear Brackets & ButtonsDyna Flex K222847Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos Medicos K222764LightForce 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.