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510(k) Data Aggregation

    K Number
    K223192
    Device Name
    XT Stain/Glaze
    Date Cleared
    2023-03-27

    (165 days)

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

    Shenzhen Xiangtong Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    XT stain/glaze are glazing porcelains used to color staining and glazing of the surfaces of dental ceramic restorations,such as glass ceramic or zirconia-based ceramic.
    Device Description
    XT stain/glaze includes glaze powder,glaze liquid,stain glaze,glaze spray. Glaze powder is composed primarily of SiO2,with components of B2O3,Al2O3, Na2O,K2O,Li2O, other oxides,and color additives. Glaze liquid is composed of deionized water and organic solvents. Stain glaze is mixed with glaze powder and glaze liquid,which can help dental professionals save the mixing process.It is in the form of a paste and applied to dental ceramic restoration surfaces by brushing.Glaze powder has 17 colors; therefore, glaze paste also has 17 colors. Glaze spray consists of glaze powder(Transparent-Glaze),organic solvent,deionized water, and Non-CFC propellant.It is supplied to dental professionals in the form of an aerosol can and applied to dental ceramic restoration surfaces by spraying. Glaze spray and stain glaze require the firing of the dental ceramic restorations after application of the glaze. During the firing process, the organic solvent and deionized water burn without being included in the dental ceramic restorations. Therefore, the final chemical composition of the dental ceramic restorations is the glaze powder.
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    K Number
    K223194
    Device Name
    Glass Ceramic
    Date Cleared
    2023-02-10

    (120 days)

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

    Shenzhen Xiangtong Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Glass Ceramic are indicated for fabricating all-ceramic restorations such as veneers, inlays, onlays, crowns, 2-unit anterior bridges, using the CAD/CAM system.
    Device Description
    Glass Ceramic is indicated for fabricating all ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the CAD/CAM system. The Glass Ceramic is composed of SiO2, Li2O, K2O, P2O5, Al2O3 and other oxides, the performance of the Glass Ceramic conforms to ISO 6872: 2015 Dentistry: Ceramic Materials. The Glass Ceramic is disposable device, and provided as non-sterile.
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