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510(k) Data Aggregation
K Number
K240912Device Name
Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)
Manufacturer
Date Cleared
2024-05-31
(58 days)
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Anhui Miisen Intelligence Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescribed by a dentist. All blanks are processed through dental laboratories or by dental professionals.
Device Description
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" 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.
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" 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 Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is supplied in different shapes, such as blocks, disc, and semi-disc, or customer ordered shapes. It is also supplied in the combinations of 21 different colors, and single and multi-layer aesthetic effect.
The different colors are originated from the different constituent of color additives (such as Fe>O3, Er>O3); and the multilayer aesthetic effect is originated from the different padding method used in the process of dry pressing.
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