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510(k) Data Aggregation

    K Number
    K062504
    Device Name
    CERAMAX
    Manufacturer
    ALPHADENT CO., LTD.
    Date Cleared
    2006-09-05

    (8 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K040420
    Predicate For
    K081200
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CeraMax is indicated for veneering of metal framework and copings for the preparation of crowns and bridges.

    Device Description

    CeraMax is a dental material product composed of Feldspar, Quartz (SiO3), A1/O1, K-CO3, Na2CO1. SnO2 ZrO2 CeO2 LinCO2, BaCO1, CaCO2, H2BO3 and color pigments including Fluorolumin. It consists of Opaque (including Powder opaque, Paste opaque and Opaque modifier), Dentine (including Dentine modifier and Opacious Dentine), Enamel, Translucent, Cervical, Glaze and Stain. They are used by dental technicians for the preparation of crowns and bridges. It is used in prosthetic dentisty by heating the powder mixture to a high temperature in a furnace to produce a hard prosthesis with a glass-like finish.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML medical device. Instead, it is a 510(k) summary and FDA clearance letter for a dental ceramic product called "CeraMax".

    This document establishes substantial equivalence of CeraMax to a predicate device (DUCERAM PLUS CERAMIC SYSTEM) based on similar technological characteristics, components, indication for use, chemical properties, and performance properties that conform to ISO standards (ISO 9693, ISO 6872) for physical properties, glass transition temperature, flexural strength, and chemical solubility. No AI/ML components or studies are mentioned.

    Therefore, I cannot fulfill your request with the provided information.

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