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510(k) Data Aggregation

    K Number
    K981335
    Device Name
    ARISTON PHC LINER
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    1998-07-02

    (80 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended Use: Ariston pHc Liner is intended to be used as an adhesive for direct light curing composite and compomer restorations.

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA 510(k) clearance letter for the Ariston pHc Liner and does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter acknowledges that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use.

    Therefore, I cannot provide the requested information based on the input text.

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