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510(k) Data Aggregation

    K Number
    K230003
    Device Name
    Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
    Date Cleared
    2023-03-31

    (87 days)

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

    Topzir Biotech Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/ CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
    Device Description
    Topzir Dental Zirconia Blank are derived from zirconia powder that has been processed into their final shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356, Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials. Topzir Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank with the addition of very small amount of inorganic pigments before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
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