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510(k) Data Aggregation

    K Number
    K082325
    Device Name
    APEXUM ABLATOR
    Manufacturer
    APEXUM LTD.
    Date Cleared
    2009-04-21

    (250 days)

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

    APEXUM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Removal of necrotic or inflamed tissue from the apical foramen and periapical region during root canal treatment.
    Device Description
    The Apexum device consists of two parts, designed to be used sequentially: the Apexum NiTi Ablator and the Apexum PGA Ablator. It is designed to remove inflamed tissue during root canal treatment with a powered handpiece device.
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