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510(k) Data Aggregation

    K Number
    K070246
    Device Name
    DOWN PAK
    Manufacturer
    ENDO TWINN B.V.
    Date Cleared
    2007-02-16

    (22 days)

    Product Code
    EKM, 872
    Regulation Number
    872.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDO TWINN B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the dental instrument heater - The Down Pak - is to provide continuous heat and/or vibration at the tip of a dental instrument. The Down Pak is designed for processing gutta percha (softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treatment. The device may only be operated by dentists and endodontists.
    Device Description
    The device is a battery-operated dental instrument heater which is designed to provide continuous heat and/or vibration at the tip of a dental instrument. The low frequency vibration stimulates the transformation of gutta percha in a solid mass. The temperature is regulated by the type of tip attached to the handpiece and it automatically maintains a preset temperature for consistent results. The cordless handpiece is easily operated by a single button and can be recharged by placing the handpiece in a charger. The tips are autoclavable and the handpiece can be disinfect with 80% alcohol.
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    K Number
    K042870
    Device Name
    ENDO TWINN
    Manufacturer
    ENDO TWINN B.V.
    Date Cleared
    2005-01-11

    (85 days)

    Product Code
    EKM, 385, 872
    Regulation Number
    872.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDO TWINN B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the dental instrument heater – The EndoTwinn - is to provide continuous heat and/or vibration at the tip of a dental instrument. The EndoTwinn is designed for processing gutta percha (cutting softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treatment The device may only be operated by dentists and endodontists.
    Device Description
    The device is a battery-operated dental instrument heater which is designed to provide continuous heat and/or vibration at the tip of a dental instrument. The low frequency vibration stimulates the transformation of gutta percha in a solid mass. The temperature is regulated by the type of tip attached to the handpiece and it automatically maintains a preset temperature for consistent results. The cordless handpiece is easily operated by a single button and can be recharged by placing the handpiece in a charger. The tips are autoclavable and the handpiece can be disinfect with 80% alcohol.
    Ask a Question

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