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510(k) Data Aggregation

    K Number
    K182017
    Device Name
    Compex HD
    Manufacturer
    AdDent, Inc.
    Date Cleared
    2019-04-29

    (276 days)

    Product Code
    QGO, EBZ, EEG, OGO
    Regulation Number
    872.6100
    Why did this record match?
    Product Code :

    QGO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Compex HD is intended to be used by a dentist or health care provider to warm and dispense dental composite materials contained in a compule or PLT (Pre Loaded Tip) to 155 degrees F (68 degrees C).
    Device Description
    The Compex HD uses a heating device to elevate the temperature of dental composite material contained in a compule (PLT) to allow it to flow and be easily extruded. It utilizes a plastic housing in the shape of a traditional dispensing qun. The housing contains a heater element(s) and/or an electrically conductive plastic compule that itself acts as a heater when a current is applied. A control circuit board assembly and rechargeable lithium lon battery are used to apply power to the heater. A separate wall plug-in USB power supply is used to charge the battery. The unit will not function with the USB power supply connected to the unit.
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