BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    TopCEM Ceramic Primer Ceramic Coupling Agent

    K Number: K242749 · Decision Nov 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    133
    Registration Numbers
    133
    Same Product Code
    410
    Applicant Total
    12
    Review Days
    57

    Basic Information

    Device Name
    TopCEM Ceramic Primer Ceramic Coupling Agent
    K Number
    K242749
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rizhao HuGe Biomaterials Company, Ltd.
    Date Received
    September 12, 2024
    Decision Date
    November 8, 2024
    Product Code
    KLE
    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
    KLE Agent, Tooth Bonding, Resin

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