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510(k) Data Aggregation

    K Number
    K081143
    Device Name
    BIOMERS TRANSLUCENT ORTHODONTIC WIRE
    Manufacturer
    BIOMERS PRODUCT, LLC
    Date Cleared
    2008-05-02

    (10 days)

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

    BIOMERS PRODUCT, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An orthodontic arch wire used to provide force to the teeth to effect movement in the early (leveling and aligning) stage of orthodontic treatment.
    Device Description
    The BioMers Translucent Orthodontic Wire is a translucent arch wire 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 theabrasion resistance properties of the wire.
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