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510(k) Data Aggregation
K Number
K190079Device Name
ArgenZ HT+
Manufacturer
The Argen Corporation
Date Cleared
2019-04-12
(86 days)
Product Code
EIH
Regulation Number
872.6660Why 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
K182833Device 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
872.6660Why 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
K143051Device Name
ArgenIS Titanium Abutments
Manufacturer
THE ARGEN CORPORATION
Date Cleared
2015-09-16
(328 days)
Product Code
NHA
Regulation Number
872.3630Why 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
K150919Device Name
ArgenZ Esthetic Plus
Manufacturer
THE ARGEN CORPORATION
Date Cleared
2015-07-13
(98 days)
Product Code
EIH
Regulation Number
872.6660Why 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
K140894Device Name
ARGEN PMMA
Manufacturer
THE ARGEN CORPORATION
Date Cleared
2014-07-31
(114 days)
Product Code
EBG
Regulation Number
872.3770Why 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
K071410Device Name
ARGEN PEARL BRAND ZIRCONIA
Manufacturer
THE ARGEN CORPORATION
Date Cleared
2007-08-15
(86 days)
Product Code
EIH
Regulation Number
872.6660Why 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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