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510(k) Data Aggregation

    K Number
    K040143
    Device Name
    MONORAIL
    Manufacturer
    NATS CORP.
    Date Cleared
    2004-09-13

    (235 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K070601
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Monorail™ Endosseous Implant is intended for use as a self-tapping screw for transitional or intra-bony long-term splinting for any length of time as decided by the Health Care provider.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a dental implant, the Dentatus Monorail™ Endosseous Implant. It describes the regulatory clearance process, the product name, and its indications for use.

    Crucially, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other details requested in your prompt. This type of information is typically found in the 510(k) summary or detailed submission, which is not provided here.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the given text.

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