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510(k) Data Aggregation

    K Number
    K092933
    Device Name
    SAF (SELF ADJUSTING FILE)
    Manufacturer
    REDENT-NOVA LTD.
    Date Cleared
    2010-01-14

    (113 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    REDENT-NOVA LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Self Adjusting file (SAF) is a mechanically operated endodontic file to be used for cleaning and shaping of root canals, as part of the procedure of root canal treatment.
    Device Description
    The ReDent SAF is an endodontic file that is indicated for use in root canal treatment for cleaning and shaping of the root canal. The file portion of the SAF consists of a metal lattice hollow cylinder and is constructed from medical grade nickel-titanium-alloy. The file's cylindrical lattice structure permits compression when inserted into the root canal followed by gradual radial expansion to fill the root canal profile. The file is surface treated by sandblasting, enabling it to file dentin from the canal's interior surface. The SAF is available in 3 standard lengths, 21mm and 25mm and 31 mm. The SAF should be mounted on a vertical-motion vibration contra-angle handpiece with a 0.4mm amplitude and vertical vibration of 3000 - 5000 OPM (oscillations per minute). The file is attached to the handpiece via a polypropylene shank.
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