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510(k) Data Aggregation

    K Number
    K974106
    Device Name
    ICON IMPLANT SYSTEM
    Date Cleared
    1998-06-01

    (213 days)

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

    BIO SCIENCE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Icon Implant System is intended for use in either partially or fully edentulous mandibles and maxillae in the following areas: - Support of fixed (cemented) restorations utilizing multiple abutments; - Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments; - Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona, or hader bar; - Terminal or intermediate abutment support for fixed bridgework; - Free standing restorations without involvement of adjacent dentition when the external hex is engaged.
    Device Description
    The Bio Science Technologies, Inc.'s Icon Implant System consists of a screw implant and a cover screw which are contained within a titanium (CP) canister. An actual implant is provided for the Reviewer. The implant and cover screw are nearly identical to the Branemark System® Mk II Self-Tapping Fixture (K945398) manufactured by Nobelpharma USA, Inc.
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