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510(k) Data Aggregation

    K Number
    K122614
    Device Name
    VINTAGE MP PRESS OVER
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2013-05-16

    (262 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VINTAGE MP PRESS OVER

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

    VINTAGE MP PRESS OVER is used to fabricate Press-To-Metal crowns and bridges.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a dental product called "VINTAGE MP PRESS OVER." This document confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria.

    The letter focuses on regulatory approval based on "substantial equivalence" and does not describe a performance study or its results in detail. It does not provide information on acceptance criteria for a performance study, reported device performance, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

    Therefore, I cannot extract the requested information from the provided text. This document is a regulatory approval letter, not a technical report detailing performance study results.

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