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510(k) Data Aggregation

    K Number
    K990954
    Device Name
    ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
    Manufacturer
    NSK NAKANISHI, INC.
    Date Cleared
    1999-06-09

    (79 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K112305
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is a control unit that drives a dc electric micromotor and turns on or off the motor by its foot switch. It is intended for use in general dental applications for work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type attachment of equal speed, speed increasing or decreasing sheath. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm.

    Device Description

    The device is a control unit that drives a dc electric micromotor and turns on or off the motor by its foot switch. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm.

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for a dental device, "Elec-Mate". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed subject to general controls.

    Therefore, I cannot provide the requested information.

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