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510(k) Data Aggregation

    K Number
    K024046
    Device Name
    TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P
    Manufacturer
    BISCO, INC.
    Date Cleared
    2003-02-06

    (62 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K014144
    Predicate For
    K123761
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TO SEAL THE SURFACE OF INDIRECT COMPOSITE RESTORATIONS, BIS ACRYL/ACRYLIC PROVISIONAL RESTORATIONS AND PROCESSED ACRYLIC APPLIANCES.

    Device Description

    BISCOVER XT/TESCERA GLAZING RESIN is a solution of methyl methacrylate and urethane acrylate supplied in a bottle.

    AI/ML Overview

    The provided text is a 510(k) summary for the BISCOVER XT/TESCERA GLAZING RESIN, indicating it is a premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and device performance metrics in the way a diagnostic AI device submission would.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text because it is not typically part of a 510(k) submission for this type of dental product. The submission is for a glazing resin, which is a material, not a diagnostic or AI-powered device.

    The document primarily focuses on:

    • Intended Use: What the device is designed to do.
    • Description: The composition and form of the device.
    • Predicate Device: A legally marketed device to which the new device is compared.
    • Substantial Equivalence: Arguments that the new device is as safe and effective as the predicate based on similar characteristics.
    • Biocompatibility: A statement that ingredients were tested and found non-toxic.

    The "Significant Performance Characteristics" table only compares the intended use, product description, and delivery system, asserting that they are substantially equivalent. It does not present quantitative performance data against specific acceptance criteria.

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