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510(k) Data Aggregation

    K Number
    K113431
    Device Name
    CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA
    Manufacturer
    Date Cleared
    2012-03-30

    (130 days)

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

    BETTINI S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Bettini BZD Zirconia Blocks are indicated for use in preparation of crowns, facings, inlays, and onlays to produce a hard prosthesis with a porcelain-like finish. The blocks are frequently used with porcelain overlay for translucence and related effects, and they are utilized to fabricate copings and frameworks for inlays, onlays, veneers, crowns, and anterior and posterior bridge restorations.
    Device Description
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