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    K Number
    K023672
    Device Name
    X O ODONTOSURGE 4
    Manufacturer
    XO CARE A/S
    Date Cleared
    2003-04-29

    (179 days)

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

    XO CARE A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The X O Odontosurge 4 is intended for use in removing soft tissue and controlling bleeding in the oral cavity in all phases of dentistry, including prosthodontics, periodontics, endodontics, pedodontics, orthodontics, oral surgery, and routine restorative dentistry.
    Device Description
    The X O Odontosurge 4 is a high frequency electrosurgery unit that is comprised of the following three principal components: Control Box, Handpiece and Cord, and seven different Electrodes contained in a separate case. The X O Odontosurge 4 is compact and easily portable. The X O Odontosurge 4 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 X O Odontosurge 4.
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