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510(k) Data Aggregation

    K Number
    K030844
    Device Name
    FINAL VARNISH LC
    Manufacturer
    Date Cleared
    2003-06-13

    (88 days)

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

    Protection of glass ionomer cement surfaces against both humidity and drying immediately after placing the filling

    Sealing and smoothing of glass ionomer cement surfaces after polishing

    Sealing of cervical margin of cementations immediately after removal of excess

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a dental device called "Final Varnish LC." It contains information about the regulatory classification, indications for use, and general compliance requirements.

    However, this document does not contain any information regarding:

    • Acceptance criteria for performance.
    • Details of a study that proves the device meets specific criteria.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Information on experts, ground truth establishment, or adjudication methods.
    • MRMC comparative effectiveness studies or standalone algorithm performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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