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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 a medical device manufactured by Mem Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-06-07 under approval 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. It is manufactured by Mem Dental Technology Co., Ltd.. The 510(k) number is K180952.

When was Ceramic Bracket approved by the FDA?

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

What company makes Ceramic Bracket?

Ceramic Bracket is manufactured by Mem Dental Technology Co., Ltd..

What is the FDA product code for Ceramic Bracket?

The FDA product code for Ceramic Bracket is NJM.

Related Clinical Trials

NCT07517601 Erbium-doped Yttrium Aluminum Garnet (Er:YAG) Laser vs Conventional Ceramic Bracket Debonding: A Split-Mouth Clinical Trial ACTIVE_NOT_RECRUITING

Other Devices by Mem Dental Technology Co., Ltd.

K242637MEM Clear Aligner System

Related Devices (Code: NJM)

K160957CDB Self Ligating Bracket 8FCdb Corporation K160615ORTHODONTIC CERAMIC BRACKETS 1.1Tomy, Inc. K152167BIJOU Orthodontic Ceramic BracketWorld Bio Tech Co., Ltd. K171844Inspire ICE aka Inspire ICE Clear BracketsOrmco Corporation K163467C-Line Orthodontic Ceramic BracketBiocetec Co., Ltd. K163117Alpha PureKoroad America

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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