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510(k) Data Aggregation

    K Number
    K032320
    Device Name
    APPOLLO 3 ALLOY
    Manufacturer
    DENTSPLY INTERNATIONAL
    Date Cleared
    2003-10-01

    (65 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K951779
    Why did this record match?
    Device Name :

    APPOLLO 3 ALLOY

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

    APOLLO 3 ALLOY is indicated as a dental alloy for fabricating inlays, crowns and small span bridges.

    Device Description

    APOLLO 3 ALLOY is a yellow, high noble, gold-based dental alloy.

    AI/ML Overview

    The provided document is a 510(k) summary for a dental alloy, APOLLO 3 ALLOY. It does not describe an AI/ML powered device, nor does it present any studies involving human readers, ground truth establishment, or performance metrics typically associated with AI/ML devices. Therefore, I cannot extract the requested information related to AI/ML device acceptance criteria and study details from this document.

    The document primarily focuses on demonstrating substantial equivalence to a predicate device (Degulor M Alloy K951779) based on its material composition, historical use, and biocompatibility testing. It states that APOLLO 3 ALLOY was found to be non-cytotoxic and non-mutagenic, and that other components have been used in legally marketed devices.

    If you have a document pertaining to an AI/ML powered device, please provide that for analysis.

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