BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    Silatrix Oral Gel

    K Number: K252425 · Decision Oct 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    83

    Basic Information

    Device Name
    Silatrix Oral Gel
    K Number
    K252425
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sa3, LLC
    Date Received
    August 1, 2025
    Decision Date
    October 23, 2025
    Product Code
    OLR
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLR Oral Wound Dressing

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    Other Clearances by Sa3, LLC

    K Number Device Name
    K202000 Silatrix Oral Gel