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510(k) Data Aggregation

    K Number
    K983470

    Validate with FDA (Live)

    Device Name
    SUPER PORCELAIN STAIN- PURE WHITE
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    1998-12-22

    (82 days)

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

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

    Device Description

    SUPER PORCELAIN STAIN - PURE WHITE

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the "Super Porcelain Stain - Pure White" device. It is not a study report and does not contain information about acceptance criteria or performance studies.

    Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval letter, not a device evaluation report.

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