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510(k) Data Aggregation

    K Number
    K063149
    Device Name
    ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM)
    Manufacturer
    T.O.A.D.S., LLC.
    Date Cleared
    2007-03-08

    (143 days)

    Product Code
    OAT
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    T.O.A.D.S., LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthodontic TAADS Screws are intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. They are intended for temporary use and should be removed after orthodontic treatment has been completed. The screws are intended for single use only.
    Device Description
    The Orthodontic TAADS Screws are single-use, screw-type, root-form endosseous dental implants designed for the anchoring of orthodontic appliances to the jaw. Each Orthodontic TAADS Screw model is designed for optimal holding power and function in a specific region of the mouth or jaw. Each model is also anodized for ease of identification through color. All of the TAADS devices are intended for immediate loading. All of the Orthodontic TAADS Screws are provided in sterile and non-sterile versions.
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