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510(k) Data Aggregation

    K Number
    K122295
    Device Name
    CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS
    Manufacturer
    CORE 3D PROTECH, S.L.
    Date Cleared
    2013-10-24

    (450 days)

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

    CORE 3D PROTECH, S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORE 3D abutment system for digital prosthetic solutions are dental abutments placed into a dental implant to provide support for dental prosthetic restorations. The abutments include: - Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abulment; - Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; - Abutment Screws to permanently fix the abutments to the Implant. Core 3D abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations. Core 3D abutments designed using CAD/CAM techniques must fulfill the Core 3D allowable range of design specifications and be provided as straight abutments only. Core 3D abutments and are compatible for use with the following dental implants: - Nobel Biocare Branemark System (K022562, K934825) - Zimmer Tapered Screwvent (K013227, K061410, K072589)
    Device Description
    The proposed devices are dental implant abutments intended to be placed into dental implants and to provide support for dental prosthetic restorations. The system is composed of the following principal components: - Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment; - Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques - Abutment Screws: to fix abutments to the underlying dental implant. The final form of the device including superstructures to titanium bases and patientspecific designs for abutment blanks may be designed using CAD CAM techniques under Core3D design specifications and limitations using the following system: - CAD/CAM Software: 3Shape Dental System including 3Shape Dental Designer - Scanner: 3Shape D810 model - Milling machine: SAUER HSC-20 DMG. Mechanical resistance of the implant-abutment connection is essential to ensure correct long-term functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established. The proposed Titanium Bases and Titanium Abutment Blanks are available with either an internal conical connection or external connection, depending on the underlying dental implant. The internal conical types are available in diameters of 3.4, 4.5, and 5.7mm for bases and in diameters of 3.5, 4.5 and 5.7mm for blanks. The external connection types are available in diameters of 3.5, 4.1 and 5.1mm.
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