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

    EASY X-TRAC SYSTEM

    K Number: K060691 · Decision Jun 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    203
    Registration Numbers
    203
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    89

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    Basic Information

    Device Name
    EASY X-TRAC SYSTEM
    K Number
    K060691
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    A. Titan Instruments, Inc.
    Date Received
    March 15, 2006
    Decision Date
    June 12, 2006
    Product Code
    EMG
    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
    EMG Forceps, Tooth Extractor, Surgical

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