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510(k) Data Aggregation

    K Number
    K102561
    Device Name
    ORTHODONTIC CERAMIC BRACKET
    Manufacturer
    Date Cleared
    2011-01-25

    (140 days)

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

    HT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MISO Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
    Device Description
    MISO Translucent Orthodontic Bracket is comprised of single crystal(mono clear sapphire) alumina. The translucent properties of the bracket make the bracket less visible than polycrystalline ceramic and metal brackets. MISO Translucent Orthodontic Bracket consists of 3parts. The bracket consists of three distinct parts: (1) arch wire slot, (2) four tie wings, and (3) base. The arch wire slot allows the placenient of an arch wire which applies the necessary force to effect tooth movement. The tie wings allow the placement of an elastic o-ring, which holds the arch wire in place. The base is adhered to a patient's tooth using adhesive, thereby anchoring the bracket to the tooth.
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