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510(k) Data Aggregation

    K Number
    K980058
    Device Name
    TOKUSO MAC BOND II
    Manufacturer
    TOKUYAMA AMERICA, INC.
    Date Cleared
    1998-04-27

    (111 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TOKUSO MAC BOND II

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

    For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth

    Device Description

    The product is a tooth enamel/dentin bonding resin for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth. It may be used in anterior and posterior applications. After mixing and applying the primer and allowing it to dry, as directed, the bonding agent is applied to the whole cavity preparation. After air drying, the bonding agent is cured with currently marketed visible light curing devices.

    AI/ML Overview

    This document is a 510(k) premarket notification for a dental bonding agent, Tokuso Mac Bond II. It confirms the device's substantial equivalence to previously marketed devices and permits its market entry. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text lacks this specific data.

    The document primarily focuses on:

    • Device Identification: Tokuso Mac Bond II, a resin tooth bonding agent.
    • Intended Use: As a bonding primer with light-cured resin filling material to enhance adhesion to the tooth in dental procedures (anterior and posterior applications).
    • Predicate Devices: Tokuso Light Bond, Scotchbond Adhesive System, Clearfil Liner Bond 2.
    • Regulatory Information: Classified as Class II, Product Code EBF.
    • Safety Information: Contains common dental materials, contraindicated for methacrylate monomer hypersensitivity, precautions for skin/eye contact, and flammability.

    To answer your specific questions, information from a different part of the 510(k) submission (e.g., performance data, bench testing results, clinical study reports) would be necessary.

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