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510(k) Data Aggregation

    K Number
    K213947
    Device Name
    Ultrasonic Endo Activation Device (Model:Actor I pro)
    Manufacturer
    ChangZhou BoMedent Medical Technology Co.,Ltd
    Date Cleared
    2022-09-08

    (265 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ChangZhou BoMedent Medical Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultrasonic Endo Activation Device (Model:Actor I pro ) is an ultrasonic-handpiece which is intended use for rootcanal cleaning and preparation. The Ultrasonic Endo Activation Device (Model:Actor I pro ) is intended for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.
    Device Description
    The subject device Ultrasonic Endo Activation Device (Model: Actor I pro) is an auxiliary device for dentists to perform root canal treatment. It is mainly used to clean the root canal with the help of ultrasonic cavitation, so as to assist dentists to complete root canal treatment. The subject device Ultrasonic Endo Activation Device (Model: Actor I pro) configuration consist of the following components: (1) ultrasonic handpiece (2) ultrasonic working tip (3) Wrench (4) silicone case (5) charging base (6) Power Adapter(7) wireless foot switch (Optional)
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