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    K Number
    K991161
    Device Name
    HYDRO-CAST ACRYLIC VARNISH, MODEL 78125
    Manufacturer
    KAY SEE DENTAL MFG. CO.
    Date Cleared
    1999-04-29

    (22 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K892452
    Why did this record match?
    Device Name :

    HYDRO-CAST ACRYLIC VARNISH, MODEL 78125

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

    Hydro-Cast Acrylic Varnish is applied to cured materials such as dentures, partial dentures, dental splints and temporary crowns/bridges for the purpose of sealing the acrylic surface.

    Device Description

    Acrylic varnish. Preparation of methyl methacrylate monomer, multifunction methacrylates, light sensitizer, polymerization.

    AI/ML Overview

    Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
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