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510(k) Data Aggregation

    K Number
    K082652
    Device Name
    BITTAR ZIRCONIA BLOCKS
    Date Cleared
    2008-12-30

    (109 days)

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

    BITTAR ZIRCONIA BLOCK, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Bittar Zirconia Blocks are indicated for use as a substructure for ceramic dental restorations. All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.
    Device Description
    Bittar Zirconia Blocks are an all ceramic core material made of high bisque fired Zirconia Oxide (ZrO2), and are provided in either block, rod or disk shape. CAD/CAM fabrication of the core material can then be used to produce copings and / or substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, crowns and bridges. The material is then fired in an oven to harden the ZrO2 The milling and final oven hardening process (i.e., sintering) is completed by the end user.
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