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510(k) Data Aggregation

    K Number
    K990790
    Device Name
    VISION PORCELAIN
    Manufacturer
    SERVO DENTAL USA, INC.
    Date Cleared
    1999-04-02

    (23 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Vision Porcelain is used in fabrication of crowns Inlays, Veneers and bridges.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for "Vision Porcelain," which is a dental material used in the fabrication of crowns, inlays, veneers, and bridges. This document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document confirming substantial equivalence to a predicate device.

    Therefore, I cannot extract any of the requested information, such as:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test sets or data provenance.
    • Number and qualifications of experts.
    • Adjudication methods.
    • Results of multi-reader multi-case studies.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • Training set sample size or ground truth establishment.
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