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FDA 510(k)

Ceramic Bracket

K-Number: K180952 · 2019-06-07

ApplicantMem Dental Technology Co., Ltd.
Decision Date2019-06-07
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ceramic Bracket is the device name listed in this FDA 510(k) record. The listed applicant is Mem Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K180952. 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 Bracket?

Ceramic Bracket is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Mem Dental Technology Co., Ltd.. The 510(k) number is K180952.

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

Ceramic Bracket received FDA 510(k) clearance on 2019-06-07, under 510(k) number K180952.

Who is the listed applicant for Ceramic Bracket?

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

What is the FDA product code for Ceramic Bracket?

The FDA product code for Ceramic Bracket is NJM.

Related Clinical Trials

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NCT07517601Erbium-doped Yttrium Aluminum Garnet (Er:YAG) Laser vs Conventional Ceramic Bracket Debonding: A Split-Mouth Clinical TrialACTIVE_NOT_RECRUITING

Other records listing Mem Dental Technology 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.

K242637MEM Clear Aligner System

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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