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510(k) Data Aggregation

    K Number
    K011926
    Device Name
    ELEC-MATE E
    Manufacturer
    NAKANISHI, INC.
    Date Cleared
    2001-09-11

    (83 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ELEC-MATE E

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is a control unit, which is connected to an ac power supply and a handpiece hose, that is a control and turns on or off or regulates the speed of the motor by the foot control of the dental unit. It has a provision for a low voltage dc power supply for the handpiece with light. It is intended as a control unit for the handpiece used in general dental applications for crown preparation, cavity preparation, finishing the crown, inlay filling, polishing, prophylaxis and endodontic treatment, with use of straight, right- and or the fining, ponsibiling, provithout internal coolant, of equal, step-up, or stepdown speed sheath. The maximum free speed of the electric micromotor is 40,000 rpm.

    Device Description

    The device is a control unit, which is connected to an ac power supply and a handpiece hose, that is a control and turns on or off or regulates the speed of the motor by the foot control of the dental unit. It has a provision for a low voltage dc power supply for the handpiece with light.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Elect-Mate E" device, an Electric Control Unit with Micromotor. It primarily addresses the device's substantial equivalence to a predicate device and its intended uses.

    However, the document does NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    Therefore, I cannot provide the requested table or answer the specific questions related to the study design and results based on the given text.

    The document only states that:

    • The device is an "Electric Control Unit with Micromotor."
    • Its regulation number is "872.4200" and regulatory class is "I."
    • It is intended for general dental applications, including crown preparation, cavity preparation, finishing the crown, inlay/filling, polishing, prophylaxis, and endodontic treatment.
    • It has a maximum free speed of the electric micromotor of 40,000 rpm.
    • The electric micromotor and its cord are not autoclavable, requiring adequate covering for infection control.

    To answer your questions, I would need a document detailing the actual performance studies conducted for the Elect-Mate E device.

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