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510(k) Data Aggregation

    K Number
    K042828
    Device Name
    OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700
    Manufacturer
    YOUNG O/S LLC
    Date Cleared
    2004-12-01

    (50 days)

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

    YOUNG O/S LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Obtura is intended for used by professionally qualified dentists, endodontists and dental clinicians to heat Gutta Percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.
    Device Description
    The device is an electrically powered dental device used for heating gutta percha and placing the softened material in prepared root canals of teeth during rot canal therapy. The Obtura is an established device that has been marketed for over 20 years with an estimated 30,000 in use worldwide. This model incorporates interchangeable handpieces, membrane switches and temperature memory controls. The user gently squeezes the trigger to express the desired amount of gutta percha in to the root canal through a soft silver applicator needle as the predicate Heated Gutta Percha System, #K832654.
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