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510(k) Data Aggregation

    K Number
    K153590
    Device Name
    AvaDent Denture Base Material
    Manufacturer
    Global Dental Science
    Date Cleared
    2016-04-22

    (128 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AvaDent Denture Base Materials are intended for the fabrication of PMMA based acrylic dental prostheses including but not limited to partial and full dentures.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a dental device, "AvaDent Denture Base Material," not a study report for an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and performance studies.

    The letter simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as CFR parts, labeling, and adverse event reporting, but not technical performance data, acceptance criteria, or study results in the context of an AI/ML algorithm.

    Without the actual study report for the device being evaluated, I cannot provide the requested information.

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