LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K203091
    Device Name
    MucoLock Oral Gel
    Manufacturer
    PCCA, Inc.
    Date Cleared
    2021-02-12

    (122 days)

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

    PCCA, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MucoLock has a mechanical action which provides management of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis or Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, traumatic ulcers caused by braces and ill-fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.
    Device Description
    MucoLock® is a low viscosity, pourable, and swish-able gel, which is presented in 16 fl. oz. bottles. This product, when washed around the mouth, forms a protective layer over the oral mucosa.
    Ask a Question

    Page 1 of 1