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510(k) Data Aggregation

    K Number
    K123904
    Device Name
    PROTHELIAL
    Manufacturer
    MUELLER MEDICAL INTERNATIONAL LLC
    Date Cleared
    2013-08-07

    (231 days)

    Product Code
    FRO, CLA
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MUELLER MEDICAL INTERNATIONAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProThelial™ & Orafate Sucralfate Malate Paste forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The paste may be used in the management of mouth lesions of all types including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery.
    Device Description
    ProThelial™ & Orafate Sucralfate Paste is an amorphous hydrogel paste formed by the controlled reaction of sucralfate with a limited quantity of malic acid and calcium carbonate solution. The amorphous hydrogel paste formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers wounds, protects against further irritation and relieves pain. ProThelial™ & Orafate Sucralfate Paste may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by reaction of sucraffate with an acid, the polymerized sucralfate self-buffers to a pH 5.0 - 7.0.
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