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    K Number
    K071858
    Device Name
    DENTAL MATRIX BAND
    Manufacturer
    FLY CAST TECHNOLOGIES, INC.
    Date Cleared
    2007-08-31

    (57 days)

    Product Code
    DZN
    Regulation Number
    872.4565
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLY CAST TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A dental matrix band is a non-sterile single use disposable device intended to be place around a tooth to keep filling material from bonding onto the other tooth. Matrix bands are used to form missing walls of prepared teeth. They shape and confine restorative materials to areas prepared to receive restorations.
    Device Description
    The Dental Matrix Band is made of medical grade stainless steel with a tin coating. The dental matrix bands are offered non-sterile single use.
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