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

    ERCH ARCH BAR, MODEL 38-690-00

    K Number: K061271 · Decision Jun 30, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    58
    Review Days
    56

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    Basic Information

    Device Name
    ERCH ARCH BAR, MODEL 38-690-00
    K Number
    K061271
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4600
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KLS-Martin L.P.
    Date Received
    May 5, 2006
    Decision Date
    June 30, 2006
    Product Code
    DYX
    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
    DYX Lock, Wire, And Ligature, Intraoral

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