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    K Number
    K990458
    Device Name
    STRAUMANN EXTRAORAL IMPLANT SYSTEM
    Manufacturer
    STRAUMANN USA
    Date Cleared
    1999-04-16

    (63 days)

    Product Code
    KCZ
    Regulation Number
    878.3800
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    Product Code :

    KCZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Straumann Extraoral implant is an endosseous implant intended for placement in the skull, mainly in the mastoid process, periorbital, and perinasal regions. Its purpose is to provide rigid retention for maxillofacial epitheses such as eye, ear and nose epitheses.
    Device Description
    The Extraoral implant is a solid, threaded, self-tapping implant made from titanium, Grade 4. It is available in insertion lengths ranging from 2.5 mm to 5.0 mm. It has the same rough surface as the as cleared Straumann endosseous dental implants in contact with bone for osseointegration and a smooth machined surface to allow for the attachment of epithelial tissue.
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