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510(k) Data Aggregation

    K Number
    K190079
    Device Name
    ArgenZ HT+
    Manufacturer
    The Argen Corporation
    Date Cleared
    2019-04-12

    (86 days)

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

    The Argen Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ArgenZ HT+ (high translucent plus) zirconia can be used for the production of full contour and substructures restorations up to a full arch.
    Device Description
    ArgenZ HT+ is a pressed Yttria stabilized Zirconia with primary oxides of Hafnium and Aluminum with naturally occurring trace oxides used to produce various shades.
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    K Number
    K182833
    Device Name
    ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer
    Manufacturer
    The Argen Corporation
    Date Cleared
    2019-02-08

    (122 days)

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

    The Argen Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ArgenZ Liquids are intended to be used by trained dental technicians as an accessory for shading ArgenZ allzirconia, monolithic restorations for anterior and posterior dental prosthetics.
    Device Description
    ArqenZ Zirconia Coloring Liguids are dilute aqueous solutions of transition and lanthanoid metal salts used in combination with ArgenZ Zirconia material (K071410 and K150919) to properly shade teeth. Elements, which may include (but are not limited to) Co, Cr, Er, Fe, Mn, Pr, Ni, Bi, and Nd are combined with water to result in the finished product.
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    K Number
    K143051
    Device Name
    ArgenIS Titanium Abutments
    Manufacturer
    THE ARGEN CORPORATION
    Date Cleared
    2015-09-16

    (328 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE ARGEN CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ArgenIS patient specific abutments are intended to be single use available by prescription only to dental professionals (dental technicians and Dentists) in the construction of dental restorations supported by endosseous dental implants. The Argen Is Abutment is designed to specifically fit an individual patients needs in order to more naturally support the tissue, esthetics, and function of the final restoration. The ArgenIS Titanium Abutments are compatible with the following implant systems: | Implant Brand and Type | Implant Diameter | | | | |------------------------------|------------------|--|--|--| | Nobel Biocare Replace Select | 3.5mm | | | | | Nobel Biocare Replace Select | 4.3mm | | | | | Nobel Biocare Replace Select | 5.0mm | | | | | Biomet 3i Certain | 3.25mm | | | | | Biomet 3i Certain | 4.0mm | | | | | Biomet 3i Certain | 5.0mm | | | | | Straumann Tissue Level - RN | 3.3mm | | | | | Straumann Tissue Level - RN | 4.1mm | | | | | Straumann Tissue Level - RN | 4.8mm | | | | | Zimmer Tapered Screw-Vent | 3.7mm | | | | | Zimmer Tapered Screw-Vent | 4.1mm | | | | | Zimmer Tapered Screw-Vent | 4.7mm | | | | | Zimmer Tapered Screw-Vent | 6.0mm | | | |
    Device Description
    Argen IS Abutments are designed specifically for an Individual patient and then milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Abutment is then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Abutment is supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw. The final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient-specific form. Minimum and Maximum Gingival Height is 0-6mm Minimum diameter at abutment/implant interface is 3.5mm to interface base Maximum length of abutment from abutment/implant interface is 12.5mm Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm Minimum wall thickness at abutment/implant interface is 0.65mm Maximal angle in relationship to the long axis of implant is 30° The proposed ArgenIS Titanium Abutments are available in a range of diameters and connection type.
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    K Number
    K150919
    Device Name
    ArgenZ Esthetic Plus
    Manufacturer
    THE ARGEN CORPORATION
    Date Cleared
    2015-07-13

    (98 days)

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

    THE ARGEN CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ArgenZ Esthetic Plus blanks are intended to be used in the fabrication of inlays, crowns, copings, and fixed bridges (up to 3 units) using various CAD/CAM systems.
    Device Description
    ArgenZ Esthetic Plus is a pressed Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder.
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    K Number
    K140894
    Device Name
    ARGEN PMMA
    Manufacturer
    THE ARGEN CORPORATION
    Date Cleared
    2014-07-31

    (114 days)

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

    THE ARGEN CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARGEN PMMA Discs are polymethylmethacrylate blanks for dental use. These blanks are used to mill long-term temporary substructures for crowns & bridgework. The blanks are intended to be used in various CAD/CAM systems.
    Device Description
    Polymethylmethacrylate (PMMA) discs or blanks for use in dental CAD/CAM systems.
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    K Number
    K071410
    Device Name
    ARGEN PEARL BRAND ZIRCONIA
    Manufacturer
    THE ARGEN CORPORATION
    Date Cleared
    2007-08-15

    (86 days)

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

    THE ARGEN CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Argen PEARL brand zirconia is intended for CAD/CAM fabrication of all-ceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.
    Device Description
    Not Found
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