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510(k) Data Aggregation

    K Number
    K984503
    Device Name
    ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000
    Manufacturer
    WALLACE A. ERICKSON & CO.
    Date Cleared
    1999-02-26

    (70 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Alpha Bond Dentin/Enamel Bonding Agent is a single solution, hydrophilic, unfilled resin that acts both as a moist dentin primer and an adhesive and is primarily used as a Primer/bonding agent between the etched dentin and/or enamel surfaces and the Restorative composite material.

    Device Description

    Alpha Bond Dentin/Enamel Bonding Agent is a single solution, hydrophilic, unfilled resin that acts both as a moist dentin primer and an adhesive.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the "Alpha Bond Dentin/Enamel Bonding Agent," indicating that the device is substantially equivalent to a predicate device.

    To answer your request, I would need a different type of document, such as a clinical study report, a device validation report, or a regulatory submission that includes performance data and acceptance criteria.

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