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510(k) Data Aggregation

    K Number
    K041645
    Device Name
    DDS-ZR
    Manufacturer
    CHARLES SCHARF
    Date Cleared
    2004-07-09

    (22 days)

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

    CHARLES SCHARF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, V (Inlays and Onlays) and as a restorative material intended for veneers, crowns, and bridges
    Device Description
    DDS-ZR is a Zirconia hybrid ceramic ideally suited for computerized dental machining applications. The dental professional prepares the appropriate tooth, sends a traditionally prepared impression to the lab where the restoration is produced, computer machined, and then returned to the dentist for placement. The dentists practice traditional luting/cementing techniques to permanently place the inlay or onlay. DDS-ZR is an alternative to gold, amalgam, porcelain, or composite filling materials, except that its application more closely resembles gold inlays or porcelain inlays or veneers used in a dental laboratory. The material is radioopaque, for ready visualization.
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