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

    LED.L, LED.M, LED.G, LED.B

    K Number: K080025 · Decision Mar 19, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    213
    Applicant Total
    14
    Review Days
    75

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    Basic Information

    Device Name
    LED.L, LED.M, LED.G, LED.B
    K Number
    K080025
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Guilin Woodpecker Medical Instrument Co., Ltd.
    Date Received
    January 4, 2008
    Decision Date
    March 19, 2008
    Product Code
    EBZ
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    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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