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510(k) Data Aggregation

    K Number
    K983247
    Device Name
    SUPER PORCELAIN ADDMATE
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    1998-11-03

    (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

    FOR USE IN PROSTHETIC DENTISTRY TO CREATE A PORCELAIN PROSTHESIS ON A FRAME OF DENTAL ALLOY .

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but without further context, the provided document does not contain information on the acceptance criteria or a study proving that a device meets those criteria. The document appears to be an FDA 510(k) clearance letter for a dental device called "SUPER PORCELAIN ADDMATE", indicating it has been found substantially equivalent to a predicate device. It specifies general information about the clearance process but does not detail performance acceptance criteria or a specific study to validate them.

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