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510(k) Data Aggregation

    K Number
    K091678
    Date Cleared
    2010-02-18

    (253 days)

    Product Code
    Regulation Number
    872.3640
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HG II SHORT FIXTURE SYSTEM

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

    The HG II Short Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The HG II Short Fixture System is for single and two stage surgical procedures. It is not for immediate load.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information about acceptance criteria and the study to prove device performance that you have requested. The document is a 510(k) clearance letter from the FDA for the "HG II Short Fixture System," which primarily focuses on the substantial equivalence determination and regulatory compliance.

    It outlines:

    • The device name and its classification (Endosseous Dental Implant, Class II).
    • The indications for use.
    • General regulatory requirements.

    However, it does not include:

    • A table of acceptance criteria and reported device performance.
    • Information on sample sizes, data provenance, or ground truth establishment for a test set.
    • Details about expert qualifications, adjudication methods, or MRMC studies.
    • Information on standalone algorithm performance or training set details.

    Therefore, I cannot fulfill your request with the given input.

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