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510(k) Data Aggregation

    K Number
    K242400
    Device Name
    Dental porcelain powder
    Date Cleared
    2024-10-10

    (58 days)

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

    Yilink (Tianjin) Biotechnology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dental porcelain powder is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.
    Device Description
    Dental porcelain powder is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure. Dental porcelain powder is composed of silicon oxide, aluminum oxide, boron oxide, potassium oxide, sodium oxide, magnesium oxide, calcium oxide, yttrium oxide, zirconium oxide, zinc oxide, strontium oxide, barium oxide, titanium oxide, titanium oxide, cerium oxide, vanadium oxide, bait oxide, praseodymium oxide, and other oxides, distilled water, 1,3-butylene glycol, 1,5-pentanediol, propanetriol, diethanolamine. The product models are categorized into pastes (PAS), powders (POW) and liquids (LIQ) depending on the form of the product. Among them, pastes are made of powders and liquids. The products are divided into different sizes according to the capacity of the different models. The products are divided into different shades according to the different shades of the models of pastes (PAS) and powders (POW), and into different shades according to the strength of volatility of the products of the model of liquids (LIQ). Dental porcelain powder is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. The main ingredients of the product include zirconia, yttrium oxide, hafnium oxide, alumina and other oxides. Through the digital scanning of the tooth or tooth mold, the three-dimensional data of the tooth mold is obtained. According to the data, the CAD design is carried out to design the porcelain block processing model. Then CNC machine tool was used to make CAM according to the porcelain block processing model, and the inner crown of all-porcelain denture was made by air sintering or vacuum sintering, so as to achieve the strength and aesthetic effect required by clinical use. Finally, the inner crown of the all-porcelain denture was glazed with porcelain powder to form the combination of porcelain, and the all-porcelain denture was made.
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    K Number
    K222513
    Device Name
    Glass Ceramics
    Date Cleared
    2023-02-10

    (175 days)

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

    Yilink (Tianjin) Biotechnology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Glass Ceramics are indicated for fabricating all-ceramic restorations such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
    Device Description
    Glass Ceramics contains glass ceramic blocks for dental use. The main ingredients of the product include Silica: 55%~65%: Lithium oxide: 12%~25%: Alumina: 2%~12%; Potassium oxide: 2%~14%; Other oxides: 0%~10%. Through the digital scanning of teeth or tooth mold, 3D data of tooth mold can be obtained. According to this data, CAD design can be carried out to design porcelain block processing model. Then, a CNC machine tool was used to manufacture the all-porcelain denture crown by CAM according to the porcelain block processing model. After air sintering or vacuum sintering, the all-porcelain denture was made to achieve the strength and aesthetic effect required by clinical use.
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    K Number
    K222520
    Device Name
    Zirconia Block
    Date Cleared
    2022-11-14

    (87 days)

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

    Yilink (Tianjin) Biotechnology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Zirconia Block is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. All blocks are processed by dental laboratories or by dental professionals.
    Device Description
    Zirconia Block is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. The main ingredients of the product include zirconia, yttrium oxide, hafnium oxide, alumina and other oxides. Through the digital scanning of the tooth or tooth mold, the three-dimensional data of the tooth mold is obtained. According to the CAD design is carried out to design the porcelain block processing model. Then CNC machine tool was used to make CAM according to the porcelain block processing model, and the inner crown of all-porcelain denture was made by air sintering or vacuum sintering, so as to achieve the strength and aesthetic effect required by clinical use. Finally, the inner crown of the all-porcelain denture was glazed with porcelain powder to form the combination of porcelain, and the all-porcelain denture was made.
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