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510(k) Data Aggregation

    K Number
    K081263
    Device Name
    STARCERAM
    Manufacturer
    H.C. STARCK CERAMICS GMBH & CO.KG
    Date Cleared
    2008-07-01

    (57 days)

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

    **H.C. STARCK CERAMICS GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Blanks made from StarCeram® Z-Med or StarCeram® Z-Al-Med HD are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
    Device Description
    Dental blanks made of StarCeram® Z-Med or StarCeram® Z-AI-Med HD are dental materials (semifinished products) made of yttrium stabilized, presintered zirconium dioxide for milled production of crowns and bridge frameworks on commercial CAD/CAM systems or handoperated copy-milling machines, with outstanding biocompatibility and high resistance against tension and pressure.
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