Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K193055
    Device Name
    Purzir Dental Zirconia
    Manufacturer
    Date Cleared
    2020-05-13

    (194 days)

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

    3DBioCAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Pürzir Dental Zirconia blanks 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
    Pürzir Dental Zirconia are disc shaped zirconia oxide blanks made available in different versions and chemical compositions of various colors, shades and dimensions and sold to dental labs that will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using Computer Aided Drafting / Computer Aided Machining (CAD / CAM) equipment. The subject device is made available in six versions: 1. HS (High Strength), 2. HT (High Translucent), 3. HT Plus (High Translucent Plus), 4. ST (Super Translucent), 5. MMT x2 (Max Multi Translucent), and 6. MMT Plus x2 (Max Multi Translucent Plus).
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1