(75 days)
Aidite Zirconia Dental Ceramics are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Aidite Zirconia Dental Ceramics are derived from zirconia powder that has been processed via uni-aixial die pressing, followed by iso-static pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices.
The provided document is a 510(k) summary for Aidite Zirconia Dental Ceramics. It explicitly states that "Clinical testing was not performed for Aidite Zirconia Dental Ceramics as part of the Pre-market Notification requirements for this submission, as dental ceramics that fall under FDA product code EIH have a long history of safe and effective use in the US."
Therefore, the device's acceptance criteria are demonstrated through physical, chemical, and biocompatibility testing against established international standards and by demonstrating substantial equivalence to a predicate device, rather than through a clinical study with human subjects.
Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the physical and mechanical properties of dental ceramics and the requirements of the predicate device, as well as the ISO standards mentioned. The document provides the device's reported physical and mechanical properties.
| Characteristic | Acceptance Criteria (Implicit from Predicate & Standards) | Reported Device Performance (Aidite Zirconia Dental Ceramics) |
|---|---|---|
| ZrO₂ | 4% (consistent with dental zirconia) | > 4% |
| HfO₂ | > 1% (consistent with dental zirconia) | > 1% |
| Al₂O₃ |
§ 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.