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

    EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM

    K Number: K063856 · Decision Feb 6, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    142
    Applicant Total
    17
    Review Days
    40

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    Basic Information

    Device Name
    EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
    K Number
    K063856
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3820
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Essential Dental Systems, Inc.
    Date Received
    December 28, 2006
    Decision Date
    February 6, 2007
    Product Code
    KIF
    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
    KIF Resin, Root Canal Filling

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