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510(k) Data Aggregation

    K Number
    K200355
    Device Name
    Duranext Abutments
    Date Cleared
    2020-07-22

    (160 days)

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

    Elegant Dental Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Duranext Abutments are intended for use with dental implants as a support for single or multiple toth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
    Device Description
    Duranext Abutments from Elegant Direct Corp. are a line of machinable blanks incorporating interface features compatible with eleven (11) endosseous dental implant system platforms (three (3) designs from two (2) manufacturers) and intended to be milled at an Elegant Direct Corp. validated milling center to produce patient-specific dental implant abutments. The subject device platform diameters range from 3.0 mm to 6.0 mm, and the corresponding compatible implant body diameters range from 3.0 mm to 6.0 mm. Duranext Abutments are designed for fabrication of custom titanium alloy dental implant abutments by a CAD/CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. The portion of each abutment available for milling is 9.5 mm in diameter and 20 mm long. The apical end is premanufactured to fit the compatible implant platform, as shown above, and is available in an engaging (anti-rotation) design. A feature at the coronal end of the abutment is provided to interface with the milling equipment. Each abutment is provided with a screw designed to fit the compatible implant. The patient-specific abutment is intended to support a cement-retained single crown or multi-unit restoration.
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