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510(k) Data Aggregation

    K Number
    K113738
    Device Name
    CREODENT SOLIDEX CUSTOM ABUTMENT
    Manufacturer
    CREODENT PROSTHETICS LTD.
    Date Cleared
    2013-09-17

    (637 days)

    Product Code
    NHA, CLA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    CREODENT PROSTHETICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following: - Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants . - Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants . - Zimmer Screw-Vent 3.7mm, 4.7mm ; Zimmer Tapered Screw-Vent , 3.7mm, 4.7mm and . 6.0mm diameter implants
    Device Description
    The Solidex® Customized Abutment is made of CP TI Gr4 grade unalloyed titanium for surgical implants applications (meets ASTM Standard F67/Gr 04-06) and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatible with: - . Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants (510K#023113) - . Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants (510K#071370) - Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and 6.0mm diameter Implants (510K#013227) The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist.
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