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510(k) Data Aggregation

    K Number
    K013881
    Device Name
    RIBBOND - TRIAXIAL
    Manufacturer
    RIBBOND, INC.
    Date Cleared
    2002-01-25

    (63 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    RIBBOND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ribbond-Triaxial is intended to provide reinforcement to acrylic or composite resins used for dental restorations. It is used by dentists and dental technicians. It can be used for the following applications: > As reinforcement in manufacturing and/or repairing full or partial-dentures as well as overdentures, night-guards and orthodontic appliances. > To repair and reinforce resin or composite prostheses including temporary and permanent bonded and removable bridges. To reinforce splints used to immobilize teeth.
    Device Description
    Ribbond-Triaxial is a fiber reinforcement used to reinforce dental resins. It is made of ultra-high-molecular-weight polyethylene (UHMW). The fibers are braided using a triaxial braid and subjected to a plasma treatment to improve its ability to bond to resins.
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