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510(k) Data Aggregation

    K Number
    K240586
    Device 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
    872.3920
    Why 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
    K203072
    Device Name
    Franz Zirconia Dental Crown
    Manufacturer
    Franz Biotech Inc.
    Date Cleared
    2022-01-19

    (467 days)

    Product Code
    ELL
    Regulation Number
    872.3920
    Why 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
    K162043
    Device Name
    NobelProcera HT ML FCZ Bridge
    Manufacturer
    Nobel Biocare AB
    Date Cleared
    2016-11-22

    (120 days)

    Product Code
    ELL
    Regulation Number
    872.3920
    Why 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
    K153534
    Device Name
    NobelProcera HT ML Full Contour Zirconia Crown
    Manufacturer
    NOBEL BIOCARE AB
    Date Cleared
    2016-06-06

    (180 days)

    Product Code
    ELL
    Regulation Number
    872.3920
    Why 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
    K071182
    Device 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
    872.3920
    Why 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
    K060530
    Device 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
    872.3920
    Why 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
    K041283
    Device Name
    PROCERA BRIDGE ZIRCONIA
    Manufacturer
    NOBEL BIOCARE AB
    Date Cleared
    2004-05-28

    (15 days)

    Product Code
    ELL
    Regulation Number
    872.3920
    Why 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
    K032562
    Device Name
    PROCEARA COPINGS AND PONTIC
    Manufacturer
    NOBEL BIOCARE AB
    Date Cleared
    2004-02-06

    (170 days)

    Product Code
    ELL
    Regulation Number
    872.3920
    Why 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
    K965216
    Device Name
    ARGI-SATIN OR OPTI0-STAR
    Manufacturer
    ARGEN PRECIOUS METALS, INC.
    Date Cleared
    1997-02-27

    (59 days)

    Product Code
    ELL
    Regulation Number
    872.3920
    Why 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
    K960770
    Device Name
    MATCHMAKER/PROPAQUE PORCELAIN
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    1996-11-19

    (267 days)

    Product Code
    ELL
    Regulation Number
    872.3920
    Why 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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