(134 days)
Erran Dental Zirconia are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers.
Normally, Erran Dental Zirconia are offered in blocks and powder and the size as shown below in Table 5-1, and are similar to the sizes and shapes of the predicate device.
There are two types of our device, one is block, another is powder. The main difference is that the blocks are made by powder, zirconia blocks is prepared and have a fixed shape, while zirconia powder is used to directly product the shape of the tooth.
Erran Dental Zirconia are derived from Zirconia powder that has been processed into their final net shapes. Erran Dental Zirconia have are then being further fabricated in to all-ceramic restoration such as crowns, bridge, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+Y2O3+HfO2+Al2O3 with its composition conforms to ISO13356-2015, Implants for Surgery-Ceramic Materials Based in Yttria-Stabilized Tetragonal Zirconia(Y-TZP). The performance of the dental zirconia conforms to ISO 6872-2015, Dentistry: Ceramic Materials.
The provided text describes the acceptance criteria and a study conducted for the Erran Dental Zirconia device. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|
| Chemical Composition (%) | Meet the ISO 13356-2015 | ZrO2+HfO2 ≥99 +Y2O3; Y2O3 4.5~6.6; HfO2 ≤5; Al2O3 ≤0.5; SiO2 ≤0.3; Fe2O3 ≤0.2 | Meet the ISO 13356-2015 |
| Appearance | There is no spot cracks and foreign matter on the surface of Erran Dental Zirconia. | There is no spot cracks and foreign matter on the surface of Erran Dental Zirconia. | Conform |
| Size (mm) | The size deviation of zirconia blocks is within 1.0mm. The weight deviation of zirconia powder is within 10g. | Meet the requirement. | Conform |
| Density (g/cm³) | Not less than 2.6, the deviation is less than 0.05 compared with marked value (3.16). | Meet the requirement. | Conform |
| Sintering Density (g/cm³) | Not less than 6.02 | 6.025 | Conform |
| Fracture Toughness (post sintering) (MPa) | At least 8 samples of the 10 samples have a fracture toughness greater than 800 | The samples met the criteria. | Conform |
| Chemical Solubility (µg/cm²) |
§ 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.