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510(k) Data Aggregation

    K Number
    K992011
    Device Name
    SYNEA-HS HIGH SPEED-HANDPIECE
    Manufacturer
    A-DEC, INC.
    Date Cleared
    1999-09-10

    (87 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-HS HIGH SPEED-HANDPIECE

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

    A dental high-speed handpiece is designed for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents describe an FDA 510(k) clearance for the Synea-HS High-Speed Handpiece (K992011). However, the documents do not contain any information about acceptance criteria, device performance testing, study design, sample sizes, expert involvement, or any of the detailed information requested in the prompt.

    The letter from the FDA (dated September 10, 1999) only states that the device is "substantially equivalent" to legally marketed predicate devices for the indications for use listed. It does not provide any data from clinical trials, performance studies, or details about the acceptance criteria used for such studies.

    Therefore, I cannot answer the specific questions posed in the prompt based on the provided text. The requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, etc., is not present in these FDA clearance letters.

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