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510(k) Data Aggregation

    K Number
    K974369
    Device Name
    APOLLO 9500
    Date Cleared
    1998-01-06

    (47 days)

    Product Code
    Regulation Number
    872.6070
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Source of illumination for curing dental restorative materials; and, Source of illumination for tooth whitening activities performed in dentistry.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or the study that proves the device meets the acceptance criteria. It is a 510(k) premarket notification approval letter for a device named "Apollo 9500" from the Food and Drug Administration (FDA).

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use: "Source of illumination for curing dental restorative materials; and, Source of illumination for tooth whitening activities performed in dentistry."

    Therefore, I cannot extract the requested information from this document.

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