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510(k) Data Aggregation

    K Number
    K063007
    Device Name
    POWERTOME PERIOTOME
    Date Cleared
    2006-10-17

    (15 days)

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

    WESTPORT MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is to be used to expand the tooth socket to facilitate tooth extraction, and/or to prepare the site for placement of endosseous dental implants or abutments.
    Device Description
    The Powertome periotome is designed as an aid to dental professionals in the extraction of a tooth, or multiple teeth, from their socket. It is designed to minimize alveolar bone loss, thus providing an initial step in the preparation prior to placing dental implants, whose success rate is highly dependent on minimal (or no) bone loss. It functions by severing the periodontal ligaments that attach the cementum of the tooth to the alveolar bone, by use of different sized and shaped tips that provide the leverage and effect desired. These ligaments are one of two methods by which teeth stay in the jaw. The second function is to push the alveolar bone away from the tooth, thus disengaging the mechanical leverage the alveolar bone uses on the imequiarity of the tooth to also help hold the tooth in place. Once the ligaments are cut, and the alveolar bone pushed away, the tooth extracts trivially. Our method is the same as using a manual periotome and mallet, except that instead of an assistant tapping on the end of the periotome with a mallet, we use a small solenoid in the handpiece, which delivers a small but consistent force on the periotome tip, controlled in duration by the professional by use of a foot switch (for on/off control). The total delivered power for each stroke is controlled, and can be set by the professional.
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