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510(k) Data Aggregation

    K Number
    K192614
    Device Name
    Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment
    Manufacturer
    MegaGen Implant CO., Ltd.
    Date Cleared
    2020-02-13

    (143 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K161689,K162867,K123988,K151789,K101890,K182091
    Why did this record match?
    Reference Devices :

    K161689, K162867, K123988, K151789, K101890

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

    The Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet is intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. Intended for fully edentulous jaw retaining a tissue supported overdenture.

    The abutments in combination with endosseous implants are used as the foundation for anchoring tooth replacements in either jaw. The attachments are used in fixed overdenture restorations that can be attached with a snap-in system.

    Device Description

    Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is a superstructure of a dental implant system to provide support for prosthetic restorations. It is intended to be used in implant-retained and removable overdenture restorations where the patient is fully edentulous. The subject device is consisted of the following devices: Meg-Ball Abutment, Metal Housing (Metal Cap, Retentive Ring), Meg-Loc Abutment, and Meg-Magnet Abutment.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for a dental device, which aims to demonstrate that a new device is substantially equivalent to existing legally marketed devices. It is not a clinical study report for an AI/ML-driven medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for AI performance and study details as it pertains to AI/ML development and validation.

    The document primarily focuses on demonstrating substantial equivalence through:

    • Comparison of Device Characteristics: Tables comparing the new device's components (Meg-Ball Abutment, Metal Cap, Retentive Ring, Meg-Loc Abutment, Meg-Magnet Abutment) against predicate and reference devices in terms of material, design, dimensions, and intended use.
    • Non-Clinical Testing: A summary of physical property tests (e.g., retentive force), biocompatibility tests (ISO 10993 standards), and surface treatment analysis, which are standard for demonstrating the safety and performance of physical medical devices.
    • No Clinical Testing: Explicitly states "No clinical studies are submitted."

    Thus, there is no AI acceptance criteria or study proving AI performance to report based on the provided text.

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