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510(k) Data Aggregation

    K Number
    K252789

    Validate with FDA (Live)

    Device Name
    Glass Ceramic
    Manufacturer
    Shenzhen Xiangtong Co., Ltd.
    Date Cleared
    2025-12-08

    (97 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Abbreviated
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K230487
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Glass Ceramic is used for the preparation of veneers, inlays, onlays, crowns, and three-unit bridges not involving molar restoration using hot press or CAD/CAM techniques.

    Device Description

    Glass Ceramic products are grouped into two main categories: CAD/CAM Glass Ceramic and Hot Press Glass Ceramic. CAD/CAM Glass Ceramic shapes include rectangular and customized shapes, and Hot Press Glass Ceramic shapes include rectangular, cylinder, and customized shapes. Glass Ceramic is available in 33 colors, and its performance conforms to ISO 6872 Dentistry: Ceramic Materials. Glass Ceramic is composed of silicon dioxide, lithium oxide, potassium oxide, phosphorus pentoxide, aluminum oxide and other oxides. This product is for prescription use only.

    AI/ML Overview

    N/A

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