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510(k) Data Aggregation

    K Number
    K133268
    Device Name
    TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS
    Manufacturer
    SCHUTZ-DENTAL GMBH
    Date Cleared
    2015-02-12

    (476 days)

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

    SCHUTZ-DENTAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tizian Blank Zirconia Reinforced Composite is made of a composite material reinforced with zirconium dioxide. The blanks can be processed with CAD/CAM technology. Optionally, the blanks can be veneered with a composite or with a monolithic material. Applications are: 1) long-term temporaries (for up to 2 years) - up to 16-unit anterior and posterior crowns and bridges, fully anatomic or reduced - only up to 2 bridge units in the posterior sector - free-end bridges with no more than one attachment 2) small permanent restorations (those must be veneered with an incisal material) - individual crowns - inlays - onlays - veneers - bridges with a maximum of 3 units.
    Device Description
    Tizian Blank Zirconia Reinforced Composite is made of a composite material reinforced with zirconium dioxide. The blanks can be processed with CAD/CAM technology. Optionally, the blanks can be veneered with a composite or with a monolithic material.
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    K Number
    K071010
    Device Name
    TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS
    Manufacturer
    SCHUTZ-DENTAL GMBH
    Date Cleared
    2007-08-24

    (137 days)

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

    SCHUTZ-DENTAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tizian Ceramic is a glass ceramic material, colored to match the VITAPAN® color system. It is used for the ceramic coating of titanium and titanium alloys as well as zirconium dioxide-based frame materials. Tizian Zr Blanks are produced of yttrium oxide-stabilized tetragonal zirconium dioxide in several different sizes for the production of full ceramic crowns, bridges and inlays.
    Device Description
    Tizian Ceramic is a glass ceramic material, colored to match the VITAPAN® color system. It is used for the ceramic coating of titanium and titanium alloys as well as zirconium dioxide-based frame materials. Tizian guarantees an easy and reliable treatment without the need for long-term cooling. Tizian Blanks are composed of tetragonal zirconium dioxide stabilized with yttrium oxide. They are available in different sizes and permit the production of ceramic crowns and bridges. The material is partially sintered and can be processed using copy milling as well as CAD/CAM procedures.
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    K Number
    K052073
    Device Name
    FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000
    Manufacturer
    SCHUTZ-DENTAL GMBH
    Date Cleared
    2005-10-26

    (86 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHUTZ-DENTAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cold-curing, methyl methacrylate resin for adding the saddles to cobalt chrome denture bases, repairs, additions and relines, and relines. Cold-curing, methyl methacrylate resin for the completion of full and partial dentures. Cold-curing, methyl methacrylate resin for adding saddles to cobalt chrome dentures bases, repairs, additions and other repairs. Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e. g. Unipress). Cold-curing repair resin for additions, replacing teeth and relining dentures. Heat-curing, methyl methacrylate resin for fabricating partial and full dentures using flasks and clamps or injection moulding systems. Heat-curing, methyl methacrylate resin, with liquid phase, for adding the saddles to cobalt chrome denture bases and other repairs.
    Device Description
    Not Found
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    K Number
    K052189
    Device Name
    REVENEER CERAMIC REPAIR SYSTEM
    Manufacturer
    SCHUTZ-DENTAL GMBH
    Date Cleared
    2005-10-17

    (67 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHUTZ-DENTAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ReVeneer is an intraoral and extraoral repair system for ceramic crown and bridge veneers with the following advantages: - no acid etching (neither hydrofluoric nor phosphoric acid) - safe intraoral use - extremely good bond strength - time saving - can be used universally, with all conventional ceramics - use of conventional curing lights (halogen, LED, plasma)
    Device Description
    ReVeneer Ceramic Repair System with the following components: 1. Primer 2. Base 3. Opaquer (light and dark) 4. Composite Fillis
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    K Number
    K051050
    Device Name
    SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092
    Manufacturer
    SCHUTZ-DENTAL GMBH
    Date Cleared
    2005-06-29

    (65 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHUTZ-DENTAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sebond Pink: Paste opaquer with integrated metal-resin bonding system, for framework retention (no additional bonder necessary) Sebond Smart: Odorless metal primer, universally suitable for all metals, guarantees a lasting bond. Sebond Grip: Increases the bond (in combination with a metal primer, e. g. Sebond Smart) between metal and opaquer, for more safety and less spalling.
    Device Description
    Not Found
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