Orthodontic Metal Reinforced Plastic Bracket

No FDA recalls on record, checked 22 Oct 2026.

Full name

Orthodonitc Metal Reinforced Plastic Bracket

510(k) Number

K942826 ↗

FDA Product Code

DYW

Device Class

Class II

Regulation

21 CFR Part 872.5470

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K920850 Active Cleared 24 Aug 1992

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  FDA 510(k) K981036 Active Cleared 5 Apr 1999

• New Base for Orthodontic Appliances

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  FDA 510(k) K771774 Active Cleared 30 Sep 1977

See all devices from Gac Intl., Inc. →

• What is the Orthodontic Metal Reinforced Plastic Bracket used for?

  It is a dental device used for orthodontic treatment, designed to attach to teeth and apply corrective forces through its plastic structure reinforced with metal components.

• How is the Orthodontic Metal Reinforced Plastic Bracket supplied and is it reusable?

  The device is supplied as a single-use item and is not intended for reuse, ensuring patient safety and preventing cross-contamination during orthodontic procedures.

• What sizes and models are available for the Orthodontic Metal Reinforced Plastic Bracket?

  The device is available in various sizes and models as specified by the manufacturer, allowing clinicians to select the appropriate fit for different tooth types and treatment needs.

• How should the Orthodontic Metal Reinforced Plastic Bracket be stored?

  It should be stored at room temperature to maintain material integrity and performance characteristics until use in orthodontic treatment.