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510(k) Data Aggregation

    K Number
    K172761
    Device Name
    New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)
    Date Cleared
    2017-11-17

    (65 days)

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

    Shanghai New Century Dental Materials Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.
    Device Description
    New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded) are derived from Zirconia powder that has been processed into their final net shapes. These blanks are then further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The zirconia powder is composed of ZrO2 + Y2O3 + HfO2 + A12O2. The performance of the dental blanks conforms to ISO 6872: 2008, Dentistry: Ceramic Materials. The shading effects of New Century All-Ceramic Dental Zirconia Blocks (Pre-Shaded) are achieved by blending different zirconia powder material, all from the same supplier; have almost identical composition, differing only in the trace amount of inorganic pigments to achieve the shading effects in dental blanks. The performance of the preshaded dental zirconia blanks also conforms to ISO 6872, Dentistry: Ceramic Materials.
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