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510(k) Data Aggregation

    K Number
    K984584
    Device Name
    AIR TECHNIQUES' DENTO-VAC
    Manufacturer
    AIR TECHNIQUES, INC.
    Date Cleared
    1999-03-22

    (88 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DENTO-VAC device is used for extra-oral evacuation of solid airborne particles from the oral cavity during dental Air Abrasion procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the Air Techniques Dento-Vac. The document is a 510(k) clearance letter from the FDA, which states that the device is substantially equivalent to legally marketed predicate devices. It does not contain details about performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested table and information.

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