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510(k) Data Aggregation

    K Number
    K110796
    Device Name
    SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE
    Manufacturer
    BIOMERS PRODUCTS, LLC
    Date Cleared
    2011-03-31

    (9 days)

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

    BIOMERS PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An orthodontic archwire used to provide force to the teeth to effect movement in orthodontic treatment.
    Device Description
    The SimpliClear Rectangular Orthodontic Wire is a translucent archwire comprised of glass fibers, a polymer composite resin, and a polymer coating. The embedded glass fibers function as the reinforcement, providing the necessary force to straighten teeth. The translucent polymer composite resin serves as the matrix, binding together the individual glass fibers. The outer coating, made of a USP Class VI polycrystalline and amorphous linear polymer, increases the abrasion resistance properties of the wire.
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    K Number
    K101481
    Device Name
    BIOMERS TRANSLUCENT ORTHODONTIC BRACKET
    Manufacturer
    BIOMERS PRODUCTS, LLC
    Date Cleared
    2010-06-23

    (26 days)

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

    BIOMERS PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
    Device Description
    The Translucent Orthodontic Bracket is comprised of single crystal alumina. The translucent properties of the bracket make the bracket less visible than polycrystalline ceramic and metal brackets. The bracket consists of three distinct parts: (1) arch wire slot, (2) four tie wings, and (3) base. The arch wire slot allows the placement 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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