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

    FIXTEMP C&B

    K Number: K102917 · Decision Jun 17, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    188
    Applicant Total
    2
    Review Days
    259

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    Basic Information

    Device Name
    FIXTEMP C&B
    K Number
    K102917
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exacta Dental Direct, Inc.
    Date Received
    October 1, 2010
    Decision Date
    June 17, 2011
    Product Code
    EBG
    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
    EBG Crown And Bridge, Temporary, Resin

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    Other Clearances by Exacta Dental Direct, Inc.

    K Number Device Name
    K142446 Fixtemp Cement