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Found 11 results
510(k) Data Aggregation
K Number
K240586Device Name
Additive Manufacturing Zirconia Customized Restoration
Manufacturer
Hangzhou Thales Medtech Co., Ltd.
Date Cleared
2024-10-03
(216 days)
Product Code
ELL, EIH
Regulation Number
872.3920Why did this record match?
Product Code :
ELL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics.
The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown, Bridge, Veneer, Inlay) that will be cemented to a natural or artificial tooth abutment.
Device Description
Additive Manufacturing Zirconia Customized Restoration is an individualized dental restoration (Crown,Bridge,Veneer,Inlay) made from zirconia slurry.
Additive Manufacturing Zirconia Customized Restoration is intended to be a replacement for a natural tooth.After finalizing the Additive Manufacturing Zirconia Customized Restoration in the laboratory.t is cemented or bonded onto a tooth or artificial abutment, by a clinician,to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.
To achieve esthetic and required value and chroma of the surrounding natural teeth the Additive Manufacturing Zirconia Customized Restoration is suitable for cut-back(veneering) or stain and glaze techniques.
The design of the Additive Manufacturing Zirconia Customized Restoration is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using or supported third party CAD systems. Once the restoration is ordered, it is sent electronically to Hangzhou Thales Medtech Co., Ltd. for fabrication.
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K Number
K203072Device Name
Franz Zirconia Dental Crown
Manufacturer
Franz Biotech Inc.
Date Cleared
2022-01-19
(467 days)
Product Code
ELL
Regulation Number
872.3920Why did this record match?
Product Code :
ELL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function.
Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.
Franz Dental Zirconia Crown is intended to be a replacement for a natural tooth.
Device Description
Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function.
Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.
Franz Zirconia Dental Crown is intended to be a replacement for a natural tooth. After finalizing the Franz Zirconia Dental Crown in the dental laboratory, it is cemented or bonded onto a tooth or artificial abutment, by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.
To achieve esthetics and required value and chroma of the surrounding natural teeth the Franz Zirconia Dental Crown is suitable for cut-back (veneering) or stain and glaze techniques.
The design of the Franz Zirconia Dental Crown is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the crown using or supported third party CAD systems. The crown, once ordered, is sent electronically to one of Franz's centralized milling centers for fabrication.
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K Number
K162043Device Name
NobelProcera HT ML FCZ Bridge
Manufacturer
Nobel Biocare AB
Date Cleared
2016-11-22
(120 days)
Product Code
ELL
Regulation Number
872.3920Why did this record match?
Product Code :
ELL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NobelProcera® HT ML FCZ Bridge is indicated for use as core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
NobelProcera® HT ML FCZ Bridge is indicated for use as a bridge that will be cemented on natural teeth or artificial abutments.
Device Description
NobelProcera®HT ML FCZ Bridge is an individualized cement retained dental restoration manufactured from translucent multi-layered zirconia material.
NobelProcera® HT ML FCZ Bridge is intended to be a replacement for a natural teeth. After finalizing the NobelProcera®HT ML FCZ Bridge in the dental laboratory, it is cemented or bonded on prepared teeth or artificial abutments by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth. To achieve esthetics and required value and chroma of the surrounding natural teeth the NobelProcera® HT ML FCZ Bridge is suitable for cut-back (veneering) or stain and glaze techniques.
The design of the NobelProcera® HT ML FCZ Bridge is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the bridge using NobelDesign or supported third party CAD systems. The bridge, once ordered, is sent electronically to one of NobelProcera's centralized milling centers for fabrication.
The NobelProcera® HT ML FCZ Bridge is manufactured from a solid piece of yitria-stabilized tetragonal zirconia. It is available in 6 shades and for bridges between 2 and 14 units.
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K Number
K153534Device Name
NobelProcera HT ML Full Contour Zirconia Crown
Manufacturer
NOBEL BIOCARE AB
Date Cleared
2016-06-06
(180 days)
Product Code
ELL
Regulation Number
872.3920Why did this record match?
Product Code :
ELL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NobelProcera HT ML FCZ Crown is indicated for use as core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
NobelProcera HT ML FCZ Crown is indicated for use as single crown that will be cemented to a natural or artificial tooth abutment.
Device Description
NobelProcera® HT ML FCZ (High Translucent Multi Lavered Full Contour Zirconia) Crown is an individualized dental restoration made from translucent multi-layered zirconia material.
NobelProcera® HT ML FCZ Crown is intended to be a replacement for a natural tooth. After finalizing the NobelProcera® HT ML FCZ Crown in the dental laboratory, it is cemented or bonded onto a tooth or artificial abutment, by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.
To achieve esthetics and required value and chroma of the surrounding natural teeth the NobelProcera® HT ML FCZ Crown is suitable for cut-back (veneering) or stain and glaze techniques.
The design of the NobelProcera® HT ML FCZ Crown is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the crown using the NobelProcera® system (NobelDesign) or supported third party CAD systems. The crown, once ordered, is sent electronically to one of NobelProcera's centralized milling centers for fabrication.
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K Number
K071182Device Name
PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013
Manufacturer
NOBEL BIOCARE AB
Date Cleared
2007-07-11
(72 days)
Product Code
ELL
Regulation Number
872.3920Why did this record match?
Product Code :
ELL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nobel Biocare's Procera Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera Bridge Zirconia may be cemented or bonded to either natural or artificial tooth abutments.
Device Description
Nobel Biocare's Procera Bridge Zirconia is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function. The Procera Bridge Zirconia is precision milled from one solid piece of densely sintered Zirconia, and can be cemented or bonded to either natural or artificial tooth abutments.
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K Number
K060530Device Name
SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.
Manufacturer
LIFECORE BIOMEDICAL, INC.
Date Cleared
2006-05-22
(83 days)
Product Code
ELL
Regulation Number
872.3920Why did this record match?
Product Code :
ELL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PrimaConnex Ceramic Copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae, in the construction of single-unit cement retained restorations.
The copings are designed to fit Lifecore's PrimaConnex Quick-Abutment.
Device Description
Lifecore Biomedical PrimaConnex Ceramic Copings are pre-manufactured for use as a core structure in the construction of single-unit cement retained restorations. The Ceramic Copings will be offered in three sizes; Small Diameter (SD), Regular Diameter (RD), and Wide Diameter (WD) to fit with the corresponding PrimaConnex Quick-Abutments, previously cleared under K051614. The Ceramic Coping contains an internal flat for anti-rotation and is cemented onto the Quick-Abutment after completion of the prosthetic restoration.
The Ceramic Copings are manufactured from Yttria-Stabilized Tetragonal Zirconia (Y-TZP) in conformance with ISO Standard 13356, Implants for Surgery – Ceramic Abutments Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP).
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K Number
K041283Device Name
PROCERA BRIDGE ZIRCONIA
Manufacturer
NOBEL BIOCARE AB
Date Cleared
2004-05-28
(15 days)
Product Code
ELL
Regulation Number
872.3920Why did this record match?
Product Code :
ELL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nobel Biocare's Procera® Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera® Bridge Zirconia may be two, three, or four units and are cemented to natural or artificial tooth abulments.
Device Description
Nobel Biocare's Procera® Bridge Zirconia is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function.
The Procera® Bridge Zirconia may be two, three, or four units and is precision milled. The Procera® Bridge Zirconia can be cemented or bonded to either natural or artificial tooth aburtments it is personalized according to the specific dimensions of the patient's abutments so the bridge precisely fits, and properly functions, in the patient's jaw.
Nobel Biocare's Procera® Bridge Zirconia is manufactured from one solid piece of densely sintered zirconia.
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K Number
K032562Device Name
PROCEARA COPINGS AND PONTIC
Manufacturer
NOBEL BIOCARE AB
Date Cleared
2004-02-06
(170 days)
Product Code
ELL
Regulation Number
872.3920Why did this record match?
Product Code :
ELL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nobel Biocare's Procera Copings and Pontic are indicated for use as core structures of an artificial prosthesis, i.e. a three-unit bridge, for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
The Pontic is indicated as the core structure of the center unit and the Copings are indicated as the core structures of the two side crowns, thereby forming the three-unit bridge.
The Copings are also indicated for use as single crowns that will be cemented to a natural or artificial tooth abutment in the treatment of partially edentulous patients in order to restore chewing function.
Device Description
Nobel Biocare's Procera® Copings and Pontic are prefabricated devices intended for use as core structures of prosthetic devices, such as three-unit bridges. The Copings are also intended for use as the core structure of single crowns.
Nobel Biocare's Procera* Copings are used with the Pontic in a three-unit bridge. The Coping serves as the core structure of the two side crowns, while the Pontic serves as the core structure of the center unit in the three-unit bridge.
Nobel Biocare's Procera" Copings are also the core structure of a single crown that can be placed on both a natural or artificial tooth abutment.
Nobel Biocare's Procera* Copings and Pontic are manufactured from either Aluminum Oxide powder or Zirconium Oxide powder. The ceramic materials (both Aluminum Oxide and Zirconium Oxide) enhance the esthetics of the restoration by giving the teeth a natural appearance.
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K Number
K965216Device Name
ARGI-SATIN OR OPTI0-STAR
Manufacturer
ARGEN PRECIOUS METALS, INC.
Date Cleared
1997-02-27
(59 days)
Product Code
ELL
Regulation Number
872.3920Why did this record match?
Product Code :
ELL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960770Device Name
MATCHMAKER/PROPAQUE PORCELAIN
Manufacturer
DAVIS SCHOTTLANDER & DAVIS, LTD.
Date Cleared
1996-11-19
(267 days)
Product Code
ELL
Regulation Number
872.3920Why did this record match?
Product Code :
ELL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The device is a feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge.
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