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510(k) Data Aggregation

    K Number
    K973247
    Device Name
    VINTAGE HALO
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    1997-10-16

    (48 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 HALO

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

    Vintage HALO is a Dental Ceramic Fused-to-Metal Restorative Material.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental ceramic material called "VINTAGE HALO". It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

    However, it does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Details about sample sizes for test sets, data provenance, or training sets.
    3. Information on expert involvement, ground truth establishment, or adjudication methods for any study.
    4. Data on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

    The document is purely an administrative clearance letter and does not describe actual performance studies or their results in the way you've outlined.

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