LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K181477
    Device Name
    MS Lide Implant Systems
    Manufacturer
    Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd
    Date Cleared
    2020-10-20

    (868 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MS Lide Implant Systems are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. The abutments are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a dental implant system. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is related to a traditional medical device (dental implants), not a software-as-a-medical-device (SaMD) or AI-powered medical device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. These are typically associated with the evaluation of AI/ML-based medical devices or diagnostic tools.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1