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510(k) Data Aggregation

    K Number
    K233016
    Device Name
    Dental Glass Ceramics
    Date Cleared
    2023-12-21

    (90 days)

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

    Shenzhen Yurucheng Dental Materials Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Once finalized into a suitable design, the Dental Glass Ceramics are indicated for use as inlays, onlays, veneer, partial crowns and crowns.
    Device Description
    Dental Glass Ceramics is composed of SiO2, Li2O, K2O,P2O5,Al2O3 and other oxides. The block is intended to be 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 or manual milling method. The block is a single-use device and provided non-sterile. The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
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    K Number
    K214003
    Device Name
    Dental Zirconia Pre-shaded Block
    Date Cleared
    2022-02-18

    (59 days)

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

    Shenzhen Yurucheng Dental Materials Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Color and Multilayer-SHT are intended for the manufacturing of partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, 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. Multilayer-3D is intended for the manufacturing of 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 and posterior tooth region. The products are categorized into class 4 according to ISO 6872. The products are suitable for all milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
    Device Description
    Dental Zirconia Pre-shaded Block is composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe2O3+Er2O3+Mn2O3). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth. Dental Zirconia Pre-shaded Block has two color representations (i.e. monolayer and multilayer), corresponding to the categories of Color and Multilayer. The Multilayer also divided into two subcategories (Multilayer-SHT and Multilayer-3D) according to the consistency of the translucency across the zirconium block. And it 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 or manual milling method. The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials. It is a single-use device, and provided non-sterile.
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    K Number
    K214005
    Device Name
    Zirconia Dental Ceramics
    Date Cleared
    2022-02-18

    (59 days)

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

    Shenzhen Yurucheng Dental Materials Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Zirconia Dental Ceramics are intended for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
    Device Description
    Zirconia Dental Ceramics is composed of yttria-stabilized zirconia. It contains ZrQz+HfO2+Y2O3 and additional Al2O3 and other oxides. It offers various shapes and dimensions suitable for different milling systems. The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials. 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 or manual milling method. The proposed device is a single-use device, and provided non-sterile.
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