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510(k) Data Aggregation

    K Number
    K182350
    Device Name
    Dental Ceramic
    Date Cleared
    2019-05-22

    (266 days)

    Product Code
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Baot Biological Technology Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dental Ceramic is indicated for use for metal-ceramic full veneers and for zirconia full veneers and partial veneers.
    Device Description
    Dental Ceramic divided into two categories: Metal Ceramic; Zirconia Ceramic. They are used to be made for simulation tooth of human whose ages above 18. After fired, form the whole or part of a dental restoration or prosthesis. It is made by Aluminium oxide(Al2O3), Silicon dioxide (SiO2), Potassium carbonate (K2CO3), Sodium carbonate (Na2CO3), Calcium oxide (CaO), Zirconium dioxide (ZrO2). Metal Ceramic: a complete metallic substructure of Dental Ceramic are Glaze separated two parts-metal and ceramic, which is made of metal alloys and whose inner is a framework. The materials within the metallic is broadly divided into three categories: precious metal, semiprecious metal alloys and non-precious metal alloys, being usually called inner alloy crown. Zirconia Ceramic: A complete Zirconia Ceramics are separated two parts-Zirconia coping and porcelain layer (Dentin layer and Enamel layer), as shown in the figure, the innermost layer of dental ceramic is Zirconia coping which is a framework. It has a positive impact on bearing and combining closely with the dentin layer.
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