Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K241316
    Device Name
    Zirconia Block
    Date Cleared
    2024-07-09

    (60 days)

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

    Hunan Hualian Special Ceramics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HT, HT-C, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML: used to make the crown, bridge, inlay, veneer of the all-porcelain restoration. UT, UT-C, UT-ML and 3D-PRO: used to make the crown, maximum 3-unit bridge, inlay, veneer of the all-porcelain restoration.
    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.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1