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510(k) Data Aggregation

    K Number
    K042400
    Device Name
    MUCOTROL CONCENTRATED ORAL GEL WAFER
    Manufacturer
    BELCHER PHARMACEUTICALS, INC.
    Date Cleared
    2004-11-24

    (82 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K013056,K964852
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MUCOTROL™ CONCENTRATED ORAL GEL WAFER HAS A MECHANICAL ACTION INDICATED FOR THE MANAGEMENT OF PAIN AND RELIEF OF PAIN, BY ADHERING TO THE MUCOSAL SURFACE OF THE MOUTH, SOOTHING ORAL LESIONS OF VARIOUS ETIQLOGIES, INCLUDING: ORAL MUCOSITIS/STOMATITIS (MAY BE CAUSED BY CHEMOTHERAPY OR RADIOTHERAPY), IRRITATION DUE TO ORAL SURGERY AND TRAUMATIC ULCERS CAUSED BY BRACES OR ILL FITTING DENTURES OR DISEASES. ALSO INDICATED FOR DIFFUSE APTHOUS ULCERS.

    Device Description

    Belcher Pharmaceutical's Mucotrol™ concentrated oral gel wafer is compressed powder, presented as 2200 mg slow dissolving wafer. This combination of substances, when slowly dissolved in the mouth, due to saliva, forms a protective layer over the oral mucosa.

    AI/ML Overview

    I am sorry, but the provided text only contains a description of a medical device (Mucotrol™ Concentrated Oral Gel Wafer) and its intended use, along with regulatory information regarding its 510(k) submission to the FDA.

    The document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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