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510(k) Data Aggregation

    K Number
    K110580
    Device Name
    NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS
    Manufacturer
    STRAUMANN USA
    Date Cleared
    2011-08-12

    (164 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K091701
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.

    Anatomic IPS e.max Abutments are indicated for screw-retained single-tooth restorations and cement-retained single tooth and bridge restorations.

    Device Description

    Narrow Connection (NC) Straumann Anatomic IPS e.max Abutments are permanent abutments intended for placement onto the Straumann Narrow Connection Bone Level Implants with the diameter of 3.3mm. The abutments are made of Zirconium Dioxide with a corresponding basal screw made of Titanium Alloy. The abutments are available in straight and 15° angled configurations with gingival heights of 2.0mm and 3.5mm, and are available in two colors of white and shaded.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (dental abutments) and does not describe software or an AI device. Therefore, it does not contain the information requested in the prompt, such as acceptance criteria for device performance related to a study, sample sizes for test/training sets, expert qualifications, or details on AI algorithms.

    The document describes the intended use, technological characteristics, and performance testing for "Narrow Connection (NC) Straumann Anatomic IPS e.max Abutments." The performance testing mentioned is "Fatigue Testing in accordance to FDA guidance document 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.'" The conclusion states that the device "met the pre-determined acceptance criteria" and "function as intended." However, it does not specify what those criteria were or provide the results of the study in detail.

    Therefore, I cannot provide the requested table or information about a study that proves a device (in the context of an AI/software device) meets acceptance criteria. The document explicitly concerns a physical dental implant component.

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