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510(k) Data Aggregation

    K Number
    K053342
    Device Name
    GENGIGEL MOUTHRINSE
    Manufacturer
    RICERFARMA SRL
    Date Cleared
    2007-03-13

    (467 days)

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

    RICERFARMA SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gengigel® Prof Gel adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Gel relieves pain by providing a barrier to protect the area from ongoing insult and discomfort. Gengigel® Prof Fluid adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Fluid relieves pain by providing a barrier to protect the area from ongoing insult and discomfort. Gengigel® Junior provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers. Gengigel® Spray provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers. Gengigel® Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers. Gengigel® Mouthrinse provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
    Device Description
    Not Found
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