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510(k) Data Aggregation

    K Number
    K133050
    Device Name
    ONE PLUS IMPLANT SYSTEM
    Manufacturer
    OSSEOFUSE, INC.
    Date Cleared
    2014-09-19

    (357 days)

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

    OSSEOFUSE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The One Plus Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The One Plus Implant System is intended for single use only. It is for delayed loading.
    Device Description
    The One Plus Implant System is a dental implant system made of Titanium 6AL 4V ELI Gr.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the intended use, the technology used, the material composition employed and performance chracteristics, The surface of this system has been treated with R.B.M and the abutment part has TiN coating on it. The One Plus Implant System is available in the following sizes. Sizes: 3.00mm (Dia.) x 11.5/13/14.5 3.75mm (Dia.) x 11.5/13/14.5 4.50mm (Dia.) x 11.5/13/14.5 5.25mm (Dia.) x 11.5/13/14.5
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    K Number
    K131748
    Device Name
    OSSEOFUSE DENTAL IMPLANT SYSTEM
    Manufacturer
    OSSEOFUSE, INC.
    Date Cleared
    2013-10-31

    (139 days)

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

    OSSEOFUSE, 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. This system is intended for delayed loading.
    Device Description
    The OsseoFuse Dental Implant System includes Hexa-Plus S fixture, Hexa-Plus S abutment, and Hexa-Plus S 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 (Resorbable Blast Media).
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