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

    Light Cure Adhesive

    K Number: K241056 · Decision Jul 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    133
    Registration Numbers
    133
    Same Product Code
    410
    Applicant Total
    2
    Review Days
    89

    Basic Information

    Device Name
    Light Cure Adhesive
    K Number
    K241056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sincera Technology (Changchun) Co., Ltd.
    Date Received
    April 18, 2024
    Decision Date
    July 16, 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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    Other Clearances by Sincera Technology (Changchun) Co., Ltd.

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