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510(k) Data Aggregation

    K Number
    K150571
    Device Name
    3i T3 Short Implants
    Manufacturer
    BIOMET3I
    Date Cleared
    2015-11-20

    (259 days)

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

    BIOMET3I

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3i T3® Short Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
    Device Description
    The 3i T3® Short Implants are manufactured from commercially pure titanium and feature a roughened apex and traditional OSSEOTITE® coronal surface. In addition, the implants are offered with or without a nano-scale discrete crystalline deposition (DCD®) calcium phosphate (CaP) surface treatment. The dental implants are basic screw-type designs available in parallel walled body geometries with an external hex connection for mating with associated Biomet 3t" external connection restorative components. The implants are offered in 5.0mm and 6.0 mm diameters and 5.0mm and 6.0mm lengths to accommodate varying patient anatomy. Size appropriate cover screws are provided with each implant.
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