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    K Number
    K201038
    Device Name
    Luce Ceramic Bracket
    Manufacturer
    Luce Castle Co., Ltd.
    Date Cleared
    2020-10-09

    (172 days)

    Product Code
    NJM
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Luce Castle Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for the orthodonic movement of teeth. It is removed after orthodontic treatment has been completed. The devices are intended to be single use only
    Device Description
    The proposed device, Luce Ceramic Bracket, consists of ceramic orthodontic brackets which are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontics wire, to alter the tooth position. The ceramic bracket is produced using AI203, translucent polycrystalline aluminum oxide (99.99%). The brackets are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle pressure to produce desired tooth movement.
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