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510(k) Data Aggregation

    K Number
    K990646
    Device Name
    PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE
    Manufacturer
    NSK NAKANISHI, INC.
    Date Cleared
    1999-03-19

    (18 days)

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

    PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE

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

    The device is a dc electric micromotor driven by the battery power pack control device with emphasis in mobility to visit schools, nursing homes, house calls, and for emergency need.

    It is intended for use in general dental applications for light work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, and endodontic treatment, with use of straight, right-angle or contra-angle ISO E-type attachment.

    Device Description

    The device is a dc electric micromotor driven by the battery power pack control device with emphasis in mobility to visit schools, nursing homes, house calls, and for emergency need.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental device called "Handy-Mate," issued on March 19, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.

    This document does NOT contain information about acceptance criteria, device performance, sample size, ground truth establishment, or any study details. It is a regulatory clearance, not a technical performance report. Therefore, I cannot extract the requested information from the provided text.

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