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510(k) Data Aggregation

    K Number
    K090747
    Device Name
    MI FLOW (GCUC-450)
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2009-06-10

    (82 days)

    Product Code
    EBF,EBC
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Restoration of Class I, II, III, IV, IV, V cavities Restoration of root surface caries Restorations in deciduous teeth Filling tunnel shaped cavities Sealing hypersensitive areas Liner/base/filling in cavity undercuts Sealant Splinting of mobile teeth Additions to composite restorations

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental material (MI Flow), not a study report for an AI-powered medical device. Therefore, it does not contain the information required to answer the prompt.

    Specifically, the document does not include:

    • Acceptance criteria table and reported device performance for an AI/CADe device.
    • Details about a study demonstrating the device meets acceptance criteria (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance).
    • Information about training sets.

    This document is a regulatory approval for a dental restorative material, confirming its substantial equivalence to previously marketed devices based on its physical and chemical properties and intended use, not its diagnostic performance based on image analysis.

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