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    K Number
    K162867
    Device Name
    MagDen Dental Implant System
    Manufacturer
    SHINHUNG MST Co., Ltd.
    Date Cleared
    2017-07-26

    (286 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K081653,K052957,K142557,K984297,K031106
    Why did this record match?
    Device Name :

    MagDen Dental Implant System

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

    The MagDen Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The MagDen Fixture devices are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. The MagDen Fixture devices are indicated for immediate loading when good primary stability is achieved.

    Device Description

    The MagDen Dental Implant System offers MagDen Fixture, two abutment types (MagDen Mini Abutment, MagDen Abutment), MagDen Implant Healing Abutment, and MagDen Implant Cover Screw. The MagDen Fixture is made of Titanium alloy (ASTM F136, Ti-6A1-4V ELI) with S.L.A surface treatment. MagDen Mini Abutment and MagDen Abutment are made of Stainless Steel (SUS444) with TiN coating. MagDen Implant Healing Abutment and MagDen Implant Cover Screw are made of titanium alloy (ASTM F136, Ti-6A1-4V ELI) with no surface treatment. The system provides immediate masticatory function for partially and completely edentulous patients.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for the MagDen Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria and results for an AI/ML device.

    Therefore, the requested information, which pertains to the acceptance criteria and study proving device performance (presumably for an AI/ML device, given the detailed questions on ground truth, human readers, and training sets), cannot be extracted from this document.

    This document describes a medical device (dental implants) and its intended use, materials, dimensions, and biocompatibility and performance tests, but these are related to the physical properties and safety of the implant itself, and not to the performance of an AI/ML algorithm.

    The sections regarding "Acceptance Criteria," "Study," "Sample Sizes," "Ground Truth," "Adjudication," "MRMC," and "Standalone Performance" are not applicable to the content of this 510(k) submission.

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