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510(k) Data Aggregation

    K Number
    K013584
    Device Name
    EXCITE SELF ETCH
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2002-01-28

    (90 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

    Excite® Self Etch is a light cured adhesive designed to bond composite and compomer to enamel and dentin. It is also an adhesive for light initiated resin cements used in conjunction with "transparent" indirect restorations, i.e. all ceramic (except zirconiumoxide) and composite restorations.

    Excite Self Etch is contraindicated for use as an adhesive with self-curing resin cements. Dual curing materials must be light initiated. This product is also contraindicated for zirconiumoxide ceramic restorations and for pulp capping.

    Device Description

    Not Found

    AI/ML Overview

    This document is a FDA 510(k) clearance letter for a dental adhesive device named "Excite Self Etch". It does not contain information about acceptance criteria or a study that proves the device meets such criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information.

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