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510(k) Data Aggregation

    K Number
    K982129
    Device Name
    ANTAGON PORCELAIN
    Manufacturer
    EUROPEAN DENTAL IMPORTS, INC.
    Date Cleared
    1998-08-04

    (48 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelainfused-to-metal elements of a fixed or removable dental prosthesis.

    Antagon Porcelain is recommended for use with any normalfusing-temperature dental ceramic alloy.

    After fabrication and finishing, the completed prosthesis is approved and placed in the patient's mouth by the dentist.

    Device Description

    Antagon Porcelain

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification FDA letter which is a regulatory document. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.

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