Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K120852
    Device Name
    ZIRCONIA BLANKS (ZIRCOSTAR)
    Manufacturer
    Date Cleared
    2012-06-06

    (77 days)

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

    KEROX LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Zirconia Blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
    Device Description
    Zirconia Blanks are dental materials (semi finished products) made of presintered zirconium dioxide for milled production of crowns and bridges frameworks on commercial CAD/CAM systems or hand operated copymilling machines, with outstanding biocompatibility and high resistance against tension and pressure. In its pre-sintered condition the product is excellently suitable for preparing dental prostheses(crowns, bridges, superstructures, inlays and olays) produced by manual and machine milling technique.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1