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    K Number
    K112045
    Device Name
    SIMPLELINE II ABUTMENT SYSTEM
    Manufacturer
    DENTIUM CO., LTD.
    Date Cleared
    2012-01-26

    (192 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    K070228,K052957,K041368
    Why did this record match?
    Device Name :

    SIMPLELINE II ABUTMENT SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SimpleLine II Abutment System is intended for use as an aid in prosthetic rehabilitation.

    Device Description

    SimpleLine II Abutment system is intended for use as an aid in prosthetic rehabilitation. It consists of Cover screw, Healing Abutment, Solid Abutment, Dual Abutment, Abutment Screw, SCA Abutment, Dual Milling Abutment, Angled Abutment (15° and 25°), Direct casting Abutment-Gold, Metal-Casting Abutment-Co-Cr, Temporary Abutment-Ti and Screw Abutment. All of abutment designs are based on existing Implantium that are cleared for marketing in the United States. The materials of the SimpleLine II Abutment System is Ti-6Al-4V ELI alloy(ASTM F136), Pure Titanium Gr4(ASTM F67). Gold alloy, Co-Cr-Mo (ASTM F799), Ti-Gr2(ASTM F67).

    The Angled Abutments are available in diameters of 3.8, 4.3, 4.5, 5.5 and 6.5mm with 15° and 25° angles to the axis of the implant.

    AI/ML Overview

    This document describes regulatory approval for a dental abutment, not an AI/ML powered device. As such, there is no information about acceptance criteria, study details, or ground truth related to AI/ML performance.

    The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through material and performance testing, typical for medical device submissions that are not AI/ML driven.

    Therefore, the requested information regarding AI/ML device performance, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set specifics cannot be extracted from the provided text.

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