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510(k) Data Aggregation

    K Number
    K991436
    Device Name
    STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION
    Manufacturer
    STERNGOLD
    Date Cleared
    1999-05-07

    (11 days)

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

    The Sterngold ImplaMed Implant can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures.

    Device Description

    Device consists of titanium screws, and titanium alloy prosthetics, brass and stainless steel restorative components, and stainless steel and titanium alloy surqical instruments.

    AI/ML Overview

    This document is a 510(k) summary for a dental implant device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is primarily focused on establishing substantial equivalence to predicate devices for regulatory clearance.

    Therefore, I cannot provide the requested information based on the provided text. The document describes the device, its intended use, technological characteristics, and comparative products, along with the FDA's clearance letter. However, it does not include details on performance studies, sample sizes, expert qualifications, ground truth establishment, or MRMC studies.

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