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510(k) Data Aggregation

    K Number
    K141400
    Device Name
    DCCERAM SYSTEM
    Date Cleared
    2015-01-28

    (245 days)

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

    **CERAMAY GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DCceram System is used to fabricate prostheses for missing/damaged teeth. The DCceram pressable ceramic ingots are pressed onto metal alloy (DCceram 12.5) or zirconia (DCceram 9.2) frames by dental technicians to fabricate ceramic restorations. DCceram 12.5 and DCceram 9.2 ceramic layering porcelains and shades are used to layer or build up the pressed ceramic to final tooth morphology and shade on the particular framework (DCceram 9.2 zirconia substructures; Dcceram 12.5 metal substructures). The DCceram conceptPress ceramic ingots are used to fabricate all-ceramic restorations. DCceram conceptArt ceramic stains and shades may be used with DCceram conceptPress or DCceram 9.2 ceramics.
    Device Description
    The DCceram System consists of several silica glass ceramic materials used to create ceramic and/or metal-ceramic dental prosthetic dental restorations, including inlays, onlays, veneers, crowns and bridges. The DCceram System components are available in a wide range of tooth shades (A1 – D4) as well as special shades. All DCceram System materials meet the physical properties requirements defined in ISO 6872:2008 Dentistry - Ceramic Materials, and are biocompatible as defined in ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry. The DCceram System components are: - DCceram 9.2 & 12.5 pressable porcelain ingots - DCceram conceptPress porcelain ingots - DCceram9.2 liner/layering porcelain - DCceram 12.5 liner/layering porcelain - DCceram12.5 stains and shades - DCceram conceptArt stains, shades and glazes The DCceram9.2 and 12.5 ingots are silicate glass-based ceramic materials designed to create dental restorations using a lost wax technique in a vacuum press. DCceram 9.2 ingots are used with zirconia frameworks; DCceram 12.5 is compatible with metal (dental alloy) frameworks. The DCceram conceptPress ingots are used to create all-ceramic dental restorations. The complete DCceram System also includes a full line of compatible liner, build-up, layering and veneering ceramics. All system materials are available in a range of tooth shades.
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