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510(k) Data Aggregation

    K Number
    K981390
    Device Name
    ODONTOSURGE 2
    Manufacturer
    PERIOGIENE
    Date Cleared
    1998-06-11

    (56 days)

    Product Code
    EKZ
    Regulation Number
    872.4920
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERIOGIENE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ODONTOSURGE 2 is intended for use in cutting (removing) soft tissue and controlling bleeding in the oral cavity during surgical procedures in all phases of dentistry, including prosthodontics, periodontics, endodontics, pedodontics, orthodontics, oral surgery, and routine restorative dentistry.
    Device Description
    The ODONTOSURGE 2 is a high frequency electrosurgery unit that is comprised of the following three principal components: control box, hand piece and cord, and six different electrodes contained in a separate case. The ODONTOSURGE 2 is compact and easily portable. The ODONTOSURGE 2 is a reusable electrosurgical unit that is used to cut and to coagulate soft tissue during procedures in all disciplines of dentistry. There is no software utilized in the operation of the ODONTOSURGE 2.
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