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510(k) Data Aggregation

    K Number
    K110577
    Device Name
    OSSEOFUSE DENTAL IMPLANT SYSTEM
    Manufacturer
    DYNAMIC INNOVATIONS INC.
    Date Cleared
    2011-07-14

    (135 days)

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

    DYNAMIC INNOVATIONS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OsseoFuse Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures and not dedicated for immediate loading. This system is intended for delayed loading.
    Device Description
    The OsseoFuse Dental Implant system includes Hexa-Plus fixture, Hexa-Plus abutment, and Lab components. This system made of Titanium intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. It is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of this system has been treated with R.B.M. Hex-Plus Fixture is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). Surface of part to be implanted into bone is treated by RBM (Resorbable Blast Media) method to increase junction strength by increasing the area of bone-implant interface. The tight and precisely fitting implant-abutment relation of the internal hexagon with internal bevel design makes abutment connection a quick and simple procedure.
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