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510(k) Data Aggregation

    K Number
    K070697
    Device Name
    COE SOFT
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2007-03-29

    (16 days)

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

    A temporary lining for acrylic dentures. For use in chair-side procedures.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for a dental device called "Coe Soft" (K070697). It's a regulatory document from the FDA, not a study report detailing acceptance criteria for an AI/software device.

    Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI/software device is not present in this document.

    This document primarily indicates that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory standard for medical devices, not a performance standard established through a clinical or algorithmic study.

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