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510(k) Data Aggregation

    K Number
    K063861
    Device Name
    GS SYSTEM
    Manufacturer
    OSSTEM IMPLANT CO.,LTD
    Date Cleared
    2007-09-21

    (267 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K062051
    Predicate For
    K072896,K073247,K073465,K080744,K081078,K081575,K090825,K101890,K122804,K182091
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GS System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or internediate abutment support for fixed bridgework. GS System is for one stage surgical procedures. It is not intended for immediate load.

    Device Description

    The GS System is a dental implant system made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

    The GS System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The differences between them are shape. The surface treatment of the SS System is R.B.M. (Resorbable Blasting Media) and that of GS system is R.B.M. or CellNest.

    The GS System is substantially equivalent in design, function and intended use to the SS System of Osstem Implant Co., Ltd.

    AI/ML Overview

    This document does not contain the information required to populate the fields of the table provided. The 510(k) submission describes a dental implant system (GS System) and argues for its substantial equivalence to a predicate device (SS System) based on similar materials, indications for use, design, and technological characteristics.

    The document states that "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations," and that the device "has been subjected to safety, performance, and product validations prior to release." However, it does not provide specific acceptance criteria, performance metrics, or details of any studies demonstrating that the device meets those criteria.

    Therefore, I cannot extract the requested information about acceptance criteria, reported device performance, sample sizes, data provenance, ground truth establishment, MRMC studies, or standalone algorithm performance.

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