(90 days)
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.
"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.
The provided document is a 510(k) summary for the "Gradual Dental Zirconia Blank" and does not describe an AI/ML device.
The content explicitly states:
- "Clinical Study is not performed for this device." (Section 5.11)
- The device is a "Gradual Dental Zirconia Blank" made from zirconia powder, used for fabricating dental restorations.
- The performance testing involved non-clinical bench testing per ISO 6872:2008 for properties like radioactivity, thermal expansion, chemical solubility, and flexural strength.
Therefore, the requested information regarding acceptance criteria and studies related to an AI/ML device, such as sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, cannot be extracted from this document as it pertains to a physical dental material, not an AI/ML software or system.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.