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FDA 510(k)

Mei Ceramic Bracket

K-Number: K190608 · 2019-11-04

ApplicantOrthosun Co., Ltd.
Decision Date2019-11-04
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Mei Ceramic Bracket is the device name listed in this FDA 510(k) record. The listed applicant is Orthosun Co., Ltd.. It received FDA 510(k) clearance on 2019-11-04 under 510(k) number K190608. 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 Mei Ceramic Bracket?

Mei Ceramic Bracket is a medical device that received FDA 510(k) clearance on 2019-11-04. The listed applicant is Orthosun Co., Ltd.. The 510(k) number is K190608.

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

Mei Ceramic Bracket received FDA 510(k) clearance on 2019-11-04, under 510(k) number K190608.

Who is the listed applicant for Mei Ceramic Bracket?

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

What is the FDA product code for Mei Ceramic Bracket?

The FDA product code for Mei 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 OrthodonticsK232011CleoAmerican OrthodonticsK231635A-Line AdvancedBiocetec Co., Ltd.K230225DynaFlex Clear Brackets & ButtonsDyna FlexK222847Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos MedicosK222764LightForce Orthodontic SystemLightforce Orthodontics

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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