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

    LED Curing Light

    K Number: K220826 · Decision Dec 8, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    213
    Applicant Total
    7
    Review Days
    261

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    Basic Information

    Device Name
    LED Curing Light
    K Number
    K220826
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Foshan Coxo Medical Instrument Co., Ltd.
    Date Received
    March 22, 2022
    Decision Date
    December 8, 2022
    Product Code
    EBZ
    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
    EBZ Activator, Ultraviolet, For Polymerization

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