BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GlasIonomer FX-LC

    K Number: K252808 · Decision Dec 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    38
    Review Days
    97

    Basic Information

    Device Name
    GlasIonomer FX-LC
    K Number
    K252808
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shofu Dental Corporation
    Date Received
    September 3, 2025
    Decision Date
    December 9, 2025
    Product Code
    EMA
    Advisory Committee
    Dental
    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
    EMA Cement, Dental

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