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510(k) Data Aggregation

    K Number
    K121117
    Device Name
    NDX ABUTMENTS
    Date Cleared
    2012-12-14

    (246 days)

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

    NATIONAL DENTEX CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NDX Custom Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
    Device Description
    NDX Custom Abutments are fabricated for a specific prosthetic case and implant interface using a Computer Assisted Design /Computer Assisted Manufacturing (CAD/CAM) scanning and milling process. Milling of NDX Custom Abutments includes anti-rotation features compatible with specific implant systems. Each abutment is made from titanium alloy. It is created according to the specific design parameters designated by the clinician. All components and parameters of the system remain identical to those cleared for the TDS Abutment System predicates. Abutments are available in diameters of 3.5, 4.1, 4.3, 5.0, 5.1, and 6.0 mm, and can be fabricated straight or with an angle up to 30°.
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