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510(k) Data Aggregation

    K Number
    K043468
    Device Name
    WILLI GELLER CREATION II PORCELAIN
    Manufacturer
    Date Cleared
    2005-01-12

    (27 days)

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

    JENSEN INT'L, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Willi Geller Creation TI Porcelain is a ceramic material intended for veneering of titanium alloy cores and substructures to form dental restorations.
    Device Description
    Williw Geller Creation TI porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations by veneering of titanium alloy cores. Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation TI substantially equivalent to the predicate device Willi Geller Creation& LF Porcelain. The safety and effectiveness of Willi Geller Creation TI , being determined by the chemical qualities and mechanical properties, is therefore equivalent to the predicate devices.
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