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

    EZX YELLOW, BLUE OR ORANGE

    K Number: K852170 · Decision Sep 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    108

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    Basic Information

    Device Name
    EZX YELLOW, BLUE OR ORANGE
    K Number
    K852170
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.1905
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Strong Marketing
    Date Received
    May 20, 1985
    Decision Date
    September 5, 1985
    Product Code
    EGZ
    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
    EGZ Holder, Film, X-Ray

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