Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K130959
    Device Name
    AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL
    Manufacturer
    Date Cleared
    2014-04-04

    (364 days)

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

    BIOPLAX LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Aftamed® Mouthwash provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologics, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery. Aftamed™ Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologics, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery. Aftamed® Spray provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations for relief of tallering to the ordination of the many film ulcers caused by braces, ill-litting dentures or oral surgery Aftamed® Shield provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery. Aftamed® Junior Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various ctiologics, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, or oral surgery.
    Device Description
    Aftamed® Mouthwash adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult. Aftamed® Gel adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult. Aftamed® Spray adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult. Aftamed® Shield adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult. A flamed® Junior Gel adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1