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510(k) Data Aggregation

    K Number
    K212765
    Device Name
    Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
    Date Cleared
    2021-11-15

    (76 days)

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

    Bloomden Bioceramics (HuNan) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HT-plus, ST, ST-C, ST-ML, SHT-C, SHT-ML, 3D-Pro-ML are intended for the manufacturing of metal-free partial and single crowns, full arch occlusally screwed bridges, inlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872. UT, UT-C, UT-ML are intended for the manufacturing of metal-free partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior tooth region. The products have to be categorized as class 4 according to ISO 6872. The products are suitable for CAD/CAM milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
    Device Description
    Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is composed of yttria-stabilized zirconia. The yttria-stabilized zirconia has a long history of safe use in dentistry. Bloomden Dental Zirconia Blank is white, and it is composed of ZrO2+HfQz+Y2O3 and additional other oxides. Bloomden Dental Zirconia Pre-Shaded Blank is color (containing 20 available Vita shades), and it contains not only the ingredients same as the white zirconia blank but also very small amount of additional inorganic pigments (Fe2O3+E12O3+MnO). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth. And there are two color representations (i.e. monolayer and multilayer) for the color zirconia blank. The proposed device is provided in various translucency (High-plus Translucency, Super Translucency, Super-high Translucency, Ultra Translucency and 3D-Pro-ML). It also offers various shapes and dimensions suitable for different milling systems. The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method. The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials. The proposed device is a single-use device, and provided non-sterile.
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