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510(k) Data Aggregation

    K Number
    K183408
    Device Name
    Jensen Shade Effect Liquids
    Manufacturer
    Jensen Industries, Inc.
    Date Cleared
    2019-03-20

    (100 days)

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

    Jensen Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K142043
    Device Name
    INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA
    Manufacturer
    JENSEN INDUSTRIES, INC.
    Date Cleared
    2014-12-18

    (143 days)

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

    JENSEN INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InSync ZR High Translucency Zirconia blanks are intended for use in construction of dental crowns, copings, inlays, and fixed partial dentures up to 3 units. While primarily intended for full contour crowns and bridges, it is also suitable for copings and substructures.
    Device Description
    InSync ZR High Translucency Zirconia is a y-tzp (yttria stabilized tetragonal zirconia polycrystals) material that features very high translucency. It is intended for use in construction of dental crowns, copings, inlays, and fixed partial dentures up to 3 units using CAD/CAM technology. While primarily intended for full contour crowns and bridges, it is also suitable for copings and substructures. InSync ZR High Translucency Zirconia meets requirements for Class 5 (type II) ceramics when tested according to ISO 6872:2008.
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    K Number
    K112806
    Device Name
    JENSEN ZIRCONIA
    Manufacturer
    JENSEN INDUSTRIES, INC.
    Date Cleared
    2011-12-01

    (65 days)

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

    JENSEN INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Jensen Zirconia consists of pressed Zirconia – Yttrium blocks intended for milling of full contour crowns, crown and bridge substructures and implant super structures to produce prostheses for replacement of missing / damaged dentition.
    Device Description
    Jensen Zirconia ceramic is pressed and sintered blocks of Yttria stabilized Zirconia used to make copings and full contour crowns for dental restorations. Restorations are fabricated according to a dental impression scanned into a computing device. By CAD/CAM technology, the blocks are machined in an automated milling machine. After machining, the units are heat treated. Full contour units may then be stained and glazed with available finishing materials. Coping units can be completed by conventional veneering with available Zr compatible dental porcelains and stained and glazed.
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    K Number
    K111743
    Device Name
    THE INSYNC CERAMIC SYSTEM
    Manufacturer
    JENSEN INDUSTRIES, INC.
    Date Cleared
    2011-09-14

    (85 days)

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

    JENSEN INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pressable ceramic pellets are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and the ceramic layering porcelain and liquids are used to build up the pressed ceramic to final tooth morphology and shade. The ceramic layering porcelain and liquids are also used in building ceramic crowns and bridges on titanium and titanium alloy substructures. Both applications are to provise protheses for missing / damaged teeth.
    Device Description
    The InSync Ceramic System consists of pressable silica based ceramic pellets and silica based ceramic layering porcelain and liquids.
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    K Number
    K070114
    Device Name
    CREATION CP-ZI PORCELAIN
    Manufacturer
    JENSEN INDUSTRIES, INC.
    Date Cleared
    2007-03-01

    (48 days)

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

    JENSEN INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Creation CP-ZI Porcelain is a pressable ceramic material intended to be used by dental technicians to construct veneers, inlays and ceramic crowns. CP-ZI can be pressed to zirconium oxide ceramic substructures for construction of ceramic crowns and bridges.
    Device Description
    Creation CP-ZI porcelain consists of pressable ceramic pellets that are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and bridges. Creation CP-ZI is also suitable a s a stand-alone press ceramic for fabricating inlays and onlays.
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    K Number
    K050838
    Device Name
    THE LF-P CERAMIC SYSTEM
    Manufacturer
    JENSEN INDUSTRIES, INC.
    Date Cleared
    2005-05-04

    (33 days)

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

    JENSEN INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    the LF-P Ceramic System is a ceramic material formed into pellets intended for pressing into full contour restorations (crowns, onlays, inlays and veners) and substructures as well as pressing to conventional precious and non-precious metal substructures. The system also includes low fusion ceramics suitable for layering or stain / glaze finishing.
    Device Description
    The LF-P Ceramic System is a ceramic material formed into pellets intended for pressing into full contour restorations (crowns, onlays, inlays and veneers) and substructures as well as pressing to conventional precious and non-precious metal substructures. The system also includes low fusion ceramics suitable for layering or stain / glaze finishing.
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    K Number
    K043201
    Device Name
    WILLI GELLER CREATION ZI PORCELAIN
    Manufacturer
    JENSEN INDUSTRIES, INC.
    Date Cleared
    2005-01-11

    (54 days)

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

    JENSEN INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Willi Geller Creation ZI Porcelain is a ceramic material intended for the veneering of zirconium oxide based cores and substructures to form dental restorations
    Device Description
    Williw Geller Creation ZI porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations by veneering of zirconium oxide-based cores.
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    K Number
    K043221
    Device Name
    WILLI GELLER CREATION CP PORCELAIN
    Manufacturer
    JENSEN INDUSTRIES, INC.
    Date Cleared
    2004-12-20

    (28 days)

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

    JENSEN INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Willi Geller Creation CP Porcelain is a pressable ceramic material intended for constructing veneer, onlay, inlay, and crown substructures and full contour restorations. Veneering of substructures can be performed with suitable conventional or low fusing porcelains such as Willi Geller Creation GC or Willi Geller Creation LF (K02904).
    Device Description
    Willi Geller Creation CP porcelain consists of pressable ceramic pellets that are used by dental technicians to fabricate full contour restorations (crowns, onlays, inlays, veneers) and substructures for full ceramic demtal restorations that are completed by being veneered with conventional or low fusing dental porcelains.
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    K Number
    K032267
    Device Name
    R&D DESIGNATION AP-052-5
    Manufacturer
    JENSEN INDUSTRIES, INC.
    Date Cleared
    2003-09-17

    (56 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    JENSEN INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelainfused-to-metal technique of fabricating dental restorations. The mechanical and rated to moter veemmake AP-052-5 suitable for use as a substrate for single unit restorations in the anterior region (Bicuspids, cuspids, and incisors)
    Device Description
    AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelain-fusedto-metal technique of fabricating dental restorations.
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    K Number
    K022206
    Device Name
    JENSEN GOLD FOIL
    Manufacturer
    JENSEN INDUSTRIES, INC.
    Date Cleared
    2002-08-29

    (55 days)

    Product Code
    EJT, JEN
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    JENSEN INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Jensen Gold Foil is pure gold direct filling gold foil suitable for use by dentists in filling Class I, Class V, Class VI, and Pit dental preparations.
    Device Description
    Jensen Gold Foil is pure gold, direct filling gold foil suitable for use by dentists in filling Class I, Class V, Class VI, and Pit dental preparations, Indications for use and chemical composition are identical to those of the predicate devices.
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