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510(k) Data Aggregation
K Number
K162323Device Name
Tooth Shade Resin Material
Manufacturer
LIAONING UPCERA CO.,LTD
Date Cleared
2017-01-12
(146 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
LIAONING UPCERA CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"Hyramic CAD/CAM Restorative" is used for dental restorations, such as full crowns, inlays/onlays and veneers.
Device Description
"Hyramic CAD/CAM Restorative" consists of inorganic filler and polymer material to form a homogeneous solid block material. The inorganic filler is derived from glass powders, while the resin is derived from methacrylate co-polymer (UDMA,TEGDMA、 and BisGMA). The formed blocks have a microstructure of inorganic materials embedded in a highly cured resin matrix. The unique combination of the two materials creates a uniform hybrid, which lends the positive physical properties of each individual material to the other. The material has been processed through various molding techniques – into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of dental restorations such as full crowns, inlays/onlays and veneers. "Hyramic CAD/CAM Restorative" is hybrid ceramic/resin dental blanks designed for the manufacture of dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. Unlike conventional ceramic restorations, customization and glaze firing is not necessary for Hyramic CAD/CAM Restorative. "Hyramic CAD/CAM Restorative" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of twenty one different colors, two different translucencies, and two different aesthetic effects (single and multilayer).
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K Number
K152175Device Name
Upcera Dental Zirconia Blank for Aesthetic Restoration
Manufacturer
LIAONING UPCERA CO.,LTD
Date Cleared
2015-12-04
(122 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
LIAONING UPCERA CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"Dental Zirconia Blank for Aesthetic Restoration" is mainly used in prosthetic treatment. When the flexural strength of Dental Zirconia Blank for Aesthetic Restoration after sintering is between 300-500 MPa, the product can be used for veneering, inlay, single crown, and substructure ceramic for three-unit prostheses not involving molar restoration; when the flexural strength of Dental Zirconia Blank for Aesthetic Restoration after sintering is over 500 MPa, it can be used for veneering, inlay, single crown, and substrate ceramic for three-unit prostheses. All blanks are processed through dental laboratories or by dental professionals.
Device Description
"Dental Zirconia Blank for Aesthetic Restoration" is derived from zirconia powder that has been processed through various molding and sintering techniques – into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. The zirconia powder is composed of ZrO2 + Y2 O3 + HfO2+ Fe2O3+ Er2O3+ Al2O3. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
"Dental Zirconia Blank for Aesthetic Restoration" is ceramic dental blanks designed for the manufacture of ceramic dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.
"Dental Zirconia Blank for Aesthetic Restoration" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of forty-six different colors, three different translucencies, and two different aesthetic effects (single and multilayer).
The different colors are originated from the different constituent of color additives (such as Fe203, Er202); the different translucencies are originated from small difference in the amount of Y2 O3, and the different aesthetic effects are originated from the different padding method used in the process of dry pressing.
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K Number
K141727Device Name
DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES)
Manufacturer
LIAONING UPCERA CO.,LTD
Date Cleared
2014-12-18
(175 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
LIAONING UPCERA CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental Lithium Disilicate Glass Ceramic Blocks (Up. Press Series and Up. CAD Series) are indicated for fabricating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
Device Description
Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series) are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li2O, P205, Al2O3, B2O3, and other oxides. It also contains inorganic pigments (Er2O3, V2O3, and MnO2) to provide different shades on the product surface. The performance of this lithium silicate dental blank conforms to ISO 6872. Dentistry: Ceramic Materials
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K Number
K141723Device Name
UPCERA COLORING LIQUID (I AND II )
Manufacturer
LIAONING UPCERA CO.,LTD
Date Cleared
2014-10-22
(118 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
LIAONING UPCERA CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Upcera Coloring Liquid (I and II) is a liquid used for the complete or partial coloration of milled Upcera zirconia substructure and anatomy before sintering.
Device Description
Upcera Coloring Liquid (I and II) are water based coloring liquids, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth. Upcera Coloring Liquid I is provided in 21 different shades, and Upcera Coloring Liquid II is provided in 16 different shades, which are corresponding to patient's closest tooth color. For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperatures.
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K Number
K141724Device Name
UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK
Manufacturer
LIAONING UPCERA CO.,LTD
Date Cleared
2014-10-22
(118 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
LIAONING UPCERA CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals.
Device Description
Upcera Dental Zirconia Blanks are derived from Zirconia powder that has been processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The zirconia powder is composed of ZrO2 + Y2O3 + HfO2 + Al2O3 with its composition conforms to ISO 13356, Implants for Surgery -- Ceramic Materials Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry: Ceramic Materials.
Upcera Dental Zirconia Pre-Shaded Blanks are derived from the same Zirconia powder as the regular Upcera Dental Zirconia Blanks, with the addition of very small amount of inorganic pigments, before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the pre-shaded dental zirconia blanks conforms to ISO 6872: 2008, Dentistry: Ceramic Materials.
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