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510(k) Data Aggregation

    K Number
    K992176
    Device Name
    EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL
    Manufacturer
    ST. GEORGE TECHNOLOGY, INC.
    Date Cleared
    2000-02-10

    (227 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Excel Ultra-Hi Formula Heat-Cured Denture Base material is indicated for use in the fabrication, repairing, relining and/or rebasing of full or partial removable prosthetic devices.

    Device Description

    Excel Ultra-Hi Formula Heat-Cured Denture Base

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA letter regarding the marketing clearance of a denture base material, not a study evaluating a medical device's performance against acceptance criteria. Therefore, I cannot extract details about acceptance criteria, device performance, study design, or expert involvement as these are not present in the text.

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