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510(k) Data Aggregation

    K Number
    K180562
    Device Name
    TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
    Manufacturer
    Zirkonzahn Gmbh
    Date Cleared
    2018-06-28

    (115 days)

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

    Zirkonzahn Gmbh

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The resin discs TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON are polymethylmethacrylate and polycarbonate discs indicated to manufacture temporary anterior and posterior crowns and bridges, with up to two adjacent pontics, that can be kept in the mouth for up to 12 months. TEMP BASIC are PMMA discs intended for the fabrication of temporary anterior crowns and bridges, with up to one adjacent pontic, with a maximum recommended usage time of 12 months. TRY-IN, BURNOUT and TRY-IN & BURNOUT are PMMA discs intended for the fabrication of temporary crowns and bridges that can be kept in the mouth for up to 24 hours as for TRY-IN, and up to 60 minutes as for BURNOUT and TRY-IN &BURNOUT.
    Device Description
    Intended use: polymer blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental crowns and bridges The subject devices are composed of polymethylmethacrylate (PMMA) or polycarbonates (PC) and pigments. They are available in different models that differ in basic material, form and color. The materials used for the submitted devices have a long history of safe use for same or equivalent indications. The blanks are available in different forms (the diameter of the block can be 95 mm or 98 mm, with step or without step) and heights (from 8 to 30mm) for different milling systems. The usage period of the subject devices is limited: TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON discs can be kept in the oral cavity for up to 12 months; TRY-IN can be kept in the oral cavity for up to 24 hours, while BURNOUT and TRY-IN & BURNOUT devices can remain in the mouth for a maximum of 60 minutes.
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    K Number
    K151490
    Device Name
    PRETTAU ANTERIOR T0
    Manufacturer
    ZIRKONZAHN GMBH
    Date Cleared
    2015-10-08

    (127 days)

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

    ZIRKONZAHN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PRETTAU® ANTERIOR T0 is intended to be used for the manufacturing of metal free single-unit anterior and posterior prostheses, inlays, onlays, veneers bonded dental restorations.
    Device Description
    PRETTAU® ANTERIOR T0 is a millable dental ceramic material made of zirconia. PRETTAU® ANTERIOR TO is destined for manufacture with CAD/CAM technology of metal free single-unit anterior and posterior prostheses, implant superstructures, inlays, onlays and veneers as fully anatomical restoration as well as for reduced structures for veneering with ceramics. The device is compatible with commercially available dental CAD/CAM systems must be validated by the user. The blocks are suitable for all milling units which are able to process presintered zirconia and which have the proper clamping device for the corresponding blank. PRETTAU® ANTERIOR TO is marketed in 25 different outer shapes, i.e. barrel, discs, rectangular, and special shapes; the blocks are produced in various heights from 10mm to 50 mm for each shape.
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    K Number
    K061851
    Device Name
    ZIRKONZAHN ICE
    Manufacturer
    ZIRKONZAHN GMBH
    Date Cleared
    2006-09-29

    (91 days)

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

    ZIRKONZAHN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Metal free single posterior crowns, multiple unit anterior crowns/bridges, inlays, onlays bonded dental restorations.
    Device Description
    Not Found
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