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    K Number
    K993526
    Device Name
    SYNEA - LS LOW-SPEED HANDPIECE
    Manufacturer
    A-DEC, INC.
    Date Cleared
    2000-01-11

    (85 days)

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

    SYNEA - LS LOW-SPEED HANDPIECE

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

    A dental low-speed handpiece is designed for removing carious material, cavity and crown preparation, excess filling material, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental low-speed handpiece. It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in the 510(k) submission itself, which is not available here.

    Therefore, I cannot provide the requested information based on the given input.

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