BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BRACE EZE

    K Number: K020009 · Decision Feb 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    198
    Registration Numbers
    198
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    40

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    Basic Information

    Device Name
    BRACE EZE
    K Number
    K020009
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6890
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Udent, Inc.
    Date Received
    January 2, 2002
    Decision Date
    February 11, 2002
    Product Code
    EGD
    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
    EGD Wax, Dental, Intraoral

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