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510(k) Data Aggregation

    K Number
    K181157
    Device Name
    Conical Plus Implant System
    Manufacturer
    OsseoFuse International, Inc.
    Date Cleared
    2019-05-24

    (388 days)

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

    OsseoFuse International, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Conical Plus Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, In support of single or multiple-unit retained, screw-retained, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. The systems is intended for delayed loading.
    Device Description
    Not Found
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