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510(k) Data Aggregation

    K Number
    K952905
    Device Name
    MINIMATIC VARIOUS IMPLANT SYSTEMS
    Manufacturer
    MINIMATIC, INC.
    Date Cleared
    1997-04-16

    (664 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K081818
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    This document, KG5505, is a 510(k) summary for a dental device, likely an implant system. It does not contain the type of AI/ML performance study data you're asking for (acceptance criteria, device performance, sample sizes, ground truth, etc.). This document predates the widespread use of AI in medical devices and is focused on establishing substantial equivalence to devices already on the market in 1995.

    Therefore, I cannot extract the requested information from the provided text.

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