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

    ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW

    K Number: K081393 · Decision Aug 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    51
    Applicant Total
    2
    Review Days
    94

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    Basic Information

    Device Name
    ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW
    K Number
    K081393
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    G & H Wire Co.
    Date Received
    May 19, 2008
    Decision Date
    August 21, 2008
    Product Code
    OAT
    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
    OAT Implant, Endosseous, Orthodontic

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    Other Clearances by G & H Wire Co.

    K Number Device Name
    K961754 SAFETY RELEASE MODULE