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510(k) Data Aggregation

    K Number
    K150141
    Device Name
    Orthodontics Bracket
    Manufacturer
    Speed Dental Co., Ltd.
    Date Cleared
    2015-10-23

    (274 days)

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

    Speed Dental Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only
    Device Description
    The brackets 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 Al203, translucent polycrystalline aluminum ox-ide(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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