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510(k) Data Aggregation

    K Number
    K232682
    Device Name
    Pre-Sintered Zirconia Coloring Liquid
    Manufacturer
    Chengdu Besmile Medical Technology Co., Ltd.
    Date Cleared
    2024-03-19

    (200 days)

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

    Chengdu Besmile Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is only used for coloring Zirconia Dental Ceramics of our company to achieve clinical aesthetic restoration.
    Device Description
    Pre-Sintered Zirconia Coloring Liquid is mainly divided into 16 colors, 26 colors and special colors. The product is mainly composed of purified water(55%~95%), ferric chloride (0~9%), Erbium Chloride(0~17%), polyethylene glycol(2%~6%),Polydextrose(0.5%~8%),Gluconic acid(1%~2%),Citric acid(0%~1%) and Yttrium chloride(0~12%).
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    K Number
    K232673
    Device Name
    Dental Glass Ceramics
    Manufacturer
    Chengdu Besmile Medical Technology Co., Ltd.
    Date Cleared
    2024-01-23

    (144 days)

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

    Chengdu Besmile Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Glass Ceramics are indicated for fabrications such as veneers, inlay/ onlay/ onlay/ partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
    Device Description
    This product is composed of SiO2 , Al2O3 , Li2O , K2O , Na2O , CeO2 , Pr6O11 , ZrO2 , P2O5 , СаО , МпО2 , Ег2Оз .
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    K Number
    K232676
    Device Name
    Dental Porcelain Powder
    Manufacturer
    Chengdu Besmile Medical Technology Co., Ltd.
    Date Cleared
    2024-01-23

    (144 days)

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

    Chengdu Besmile Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is indicated for use as a veneering material for fixed prosthesis in crowns, bridges.
    Device Description
    This product includes Porcelain Powder, Stain/Glaze and Blending liquid. The porcelain powder is composed of silica (SiOz), alumina (AlzOs), potassium oxide (K2O), sodium oxide (Na2O), boron trioxide (B2O3), calcium oxide (CaO), barium oxide (BaO), zirconia (ZrO2), zinc oxide (ZnO) , lithium oxide (Li₂O), tin oxide (SnO₂), magnesium oxide (MgO), Yttrium oxide (Y2O3) and terbium oxide (Tb2Os).. The blending liquid is composed of purified water, 1, 3-butanediol and diethanolamine. The Stain/Glaze is composed of the porcelain powder and the blending liquid in accordance with the mass ratio of 1:1.
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