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

    CL-DC20, CL-DC21

    K Number: K093751 · Decision Feb 24, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    213
    Applicant Total
    7
    Review Days
    79

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    Basic Information

    Device Name
    CL-DC20, CL-DC21
    K Number
    K093751
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Good Doctors Co., Ltd.
    Date Received
    December 7, 2009
    Decision Date
    February 24, 2010
    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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