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510(k) Data Aggregation

    K Number
    K043295
    Device Name
    VERSYO.DIRECT
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2005-01-05

    (37 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VERSYO.DIRECT

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

    Versyo.direct is a 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 the provided text is a 510(k) premarket notification decision letter from the FDA for a dental bonding agent (Versyo®.direct). It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    The letter confirms the device's substantial equivalence to a predicate device based on its indications for use and regulatory classification. It outlines regulatory requirements for marketing the device but does not include details about performance studies, sample sizes, ground truth establishment, or expert reviews, which would typically be found in a submission summary or a scientific study report.

    Therefore, I cannot provide the requested information.

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