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510(k) Data Aggregation

    K Number
    K112640
    Device Name
    HYPERELASTIC WIRE
    Manufacturer
    ORMCO CORP.
    Date Cleared
    2011-11-16

    (65 days)

    Product Code
    DZC
    Regulation Number
    872.5410
    Why did this record match?
    Product Code :

    DZC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hyperelastic Archwire is indicated for use as an orthodontic arch wire to aid in the movement of teeth during the early phase of orthodontic treatment. The Hyperelostic Archwire may be used in conjunction with metallic, ceramic, or plastic brackets.
    Device Description
    Hyperelastic Archwire is a metallic shape memory alloy orthodontic archwire for maxillary and mandibular arches. This alloy exerts low constant forces, retains elastic properties at large strains, with low frictional binding properties.
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