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

    MICRODOSE RC-EZ

    K Number: K924825 · Decision Mar 5, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    22
    Applicant Total
    9
    Review Days
    158

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    Basic Information

    Device Name
    MICRODOSE RC-EZ
    K Number
    K924825
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Unicep
    Date Received
    September 28, 1992
    Decision Date
    March 5, 1993
    Product Code
    EKM
    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
    EKM Gutta-Percha

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