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510(k) Data Aggregation

    K Number
    K033629
    Device Name
    VERSYO.BOND
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2003-12-22

    (33 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Versyo.bond is light curing, methyl methacrylate free conditioner for the bonding of light curing prosthetic base materials to heat, self or light curing PMMA denture base materials and artificial teeth based on PMMA.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot fulfill your request. The document is a 510(k) premarket notification approval letter for a dental bonding agent named "Versyo®.bond". It confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory compliance requirements.

    However, the document does not contain any information about clinical studies, performance data, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications. The approval letter is a regulatory document, not a scientific study report.

    Therefore, I cannot extract the specific details you've requested regarding acceptance criteria and a study proving device performance because that information is not present in the provided text.

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