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510(k) Data Aggregation
K Number
K240153Device Name
Ceramic Etchant (HF-5 and HF-9)
Manufacturer
Liaoning Upcera Co., Ltd
Date Cleared
2024-10-02
(257 days)
Product Code
KLE, EIH, PME
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Liaoning Upcera Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ceramic Etchant is intended for etching the porcelain veneers, crowns, and inlays extraorally. It is also used for pretreating the porcelain veneers, crowns, and inlays extraorally before bonding.
Device Description
Not Found
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K Number
K231687Device Name
Gradual Dental Zirconia Blank
Manufacturer
Liaoning UPCERA CO., Ltd
Date Cleared
2023-09-07
(90 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
The device is indicated for fabrication of anterior and posterior dental restorations using different CAD/CAM or manual machines. All blanks are processed through dental laboratories or by dental professionals.
Device Description
"Gradual Dental Zirconia Blank" 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 , Y2O3, HfO2 and other oxides. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
"Gradual Dental Zirconia Blank" 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.
"Gradual Dental Zirconia Blank" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of fifty different colors, gradual changing translucencies, and multi-layer aesthetic effect.
The different colors are originated from the different constituent of color additives (such as Fe2O3, Er2O3); the different translucencies are originated from small difference in the amount of Y2 O3, and the multilayer aesthetic effect is originated from the different padding method used in the process of dry pressing.
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K Number
K181167Device Name
Upcera Glaze Paste, Glaze Powder, and Glaze Liquid
Manufacturer
Liaoning Upcera Co., Ltd
Date Cleared
2018-09-02
(123 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
"Glaze Paste, Glaze Powder, and Glaze Liquid" are indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.
Device Description
"Glaze Paste, Glaze Powder, and Glaze Liquid" is a dental veneering material used for color staining and glazing of the surfaces of restorations such as porcelain-fused zirconia, full-contoured zirconia, or lithium disilicate. The intended use of general porcelain is to make the artificial teeth (dental prosthesis) more similar with natural teeth.
"Glaze Paste, Glaze Powder, and Glaze Liquid" are actually three products: Powder, paste, and liquid. "Glaze Powder" is in the form of a porcelain dry powder and liquid. When mixed together by the technician at a dental lab, they form the paste stain before applied to the patient.
"Glaze Paste" is pre-mixed paste from porcelain powder and liquid, which can help dental technicians save the mixing process.
The porcelain powder is composed primarily of SiO2, with minor components of Al2O3, K20, Na2O, Li2O, and color additives. The liquid is composed of deionized water and organic solvents. The liquid can also be used as a thinner to control viscosity of paste.
"Glaze Paste, Glaze Powder, and Glaze Liquid" are supplied in seventy one different colors, with or without fluorescence effect.
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