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510(k) Data Aggregation

    K Number
    K972569
    Device Name
    E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION
    Manufacturer
    NSK NAKANISHI, INC.
    Date Cleared
    1997-10-08

    (90 days)

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

    E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION

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

    The device is intended for use where high speed such as 200,000 rpm is required in general dentistry with or without use of coolant; such as cutting a tooth for cavity and/or crown preparation and finishing, cutting and/or finishing of dentures, denture bases, crowns, inlays and metal plates. The device is driven by an electric micromotor or an air motor handpiece that has the ISO-3964 Coupling.

    Device Description

    E-Type Speed Increaser Contra Angle, ES-95

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental device. It does not contain information regarding acceptance criteria, a study proving performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    Therefore, I cannot fulfill your request using the provided text. The document's purpose is to state that the device is substantially equivalent to legally marketed predicate devices and can now be marketed, not to detail the performance studies and criteria.

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