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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
    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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    K Number
    K093559
    Device Name
    VINTAGE MP
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2010-03-03

    (105 days)

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

    VINTAGE MP

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

    VINTAGE MP is paste or powder porcelain intended to fabricate metal-ceramic restorations. It is used in conjunction with precious alloys for metal-ceramic restoration, metals for metal-ceramic restoration and stain materials for metalceramic restoration in order to produce natural looking restorations and prostheses.

    Device Description

    VINTAGE MP is paste or powder porcelain

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a dental porcelain product, "Vintage MP." It is not a study report and therefore does not contain the information requested regarding acceptance criteria and device performance studies.

    The letter simply states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. It outlines regulatory requirements for marketing the device but does not include any performance data or study details.

    To answer your questions, one would need to refer to the actual 510(k) submission document, which is not provided here.

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