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510(k) Data Aggregation

    K Number
    K131664
    Device Name
    COPRA TEMP PMMA-DISK
    Manufacturer
    WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG
    Date Cleared
    2013-12-18

    (194 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    **WHITE PEAKS DENTAL SYSTEMS GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    White Peaks Copra Temp is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.
    Device Description
    White Peaks Copra Temp is a device made from high quality 100% PMMA (polymethylmethacrylate) and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Two (2) pontics are allowed between two (2) abutment teeth. Restorations are designed using CAD technology and uses scans or models for the basis of the restoration to be milled. Copra Temp Blanks are available in a variety of thicknesses for different milling systems and are also available in a variety of Vita shades.
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    K Number
    K123680
    Device Name
    COPRANCOLOR
    Manufacturer
    WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG
    Date Cleared
    2013-02-21

    (83 days)

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

    **WHITE PEAKS DENTAL SYSTEMS GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CopranColor is intended to be used as the coloring agent for the shading of white zirconia ceramic materials that are intended to be used by professional dental technicians to fabricate all-ceramic dental restorations for the sole use of particular patients.
    Device Description
    CopranColor is a device that may be used as an accessory to zirkonium dioxide dental restaurations such as Copran ZR /Origin YZ. Together with the zirconium dioxide blanks the CopranColor can be used by professional dental technicians for fabrication of all.ceramic restorations.
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    K Number
    K092496
    Device Name
    COPRAN ZR/ORIGIN YZ
    Manufacturer
    WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG
    Date Cleared
    2009-09-18

    (35 days)

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

    **WHITE PEAKS DENTAL SYSTEMS GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Copran Zr/ Origin YZ Zirconia blanks are presintered blanks for CAD CAM or manual milling, made from biocompatible, tetragonal and polycrystalline zirconiumdioxyde. Milling blanks designed for: - Crown frameworks in the anterior and posterior areas - Bridge frameworks in the anterior and posterior areas - Primary conical crowns and telescopic crowns - Cantilevered bridges with a max. of one pontic having a premolar width - Inlays, Onlays, Veneers
    Device Description
    Copran Zr/ Origin YZ Zirconia blanks are presintered blanks for CAD CAM or manual milling, made from biocompatible, tetragonal and polycrystalline zirconiumdioxyde. The devices are sold in different shapes, figures and dimensions to match the specification of the different CAD/CAM milling machines used to generate the final restaurations. This may be shapes like disks, cubes, bars and cylinders.
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