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

    COMPOTHIXO

    K Number: K111465 · Decision Jul 25, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    371
    Registration Numbers
    371
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    426

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    Basic Information

    Device Name
    COMPOTHIXO
    K Number
    K111465
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kerrhawe SA
    Date Received
    May 26, 2011
    Decision Date
    July 25, 2012
    Product Code
    DZN
    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
    DZN Instruments, Dental Hand

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