(144 days)
Dental Glass Ceramics are indicated for fabrications such as veneers, inlay/ onlay/ onlay/ partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
This product is composed of SiO2 , Al2O3 , Li2O , K2O , Na2O , CeO2 , Pr6O11 , ZrO2 , P2O5 , СаО , МпО2 , Ег2Оз .
The provided document is a 510(k) Premarket Notification for a medical device called "Dental Glass Ceramics". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or developing an AI algorithm. Therefore, many of the requested categories for AI-based device studies are not applicable to this document.
Here's an analysis based on the information available:
1. Table of acceptance criteria and the reported device performance
| ID# | Test | Method | Acceptance Criteria | Test Result | Conclusion |
|---|---|---|---|---|---|
| 1.1 Material Composition Content | |||||
| Silicon dioxide (SiO2) | Ingredient Content (%) | 60~75 | 68.32% | Pass | |
| Alumina (Al2O3) | Ingredient Content (%) | 2~7 | 4.02% | Pass | |
| Lithium oxide (Li2O) | Ingredient Content (%) | 5~17 | 13.09% | Pass | |
| Potassium oxide + sodium oxide (K2O+Na2O) | Ingredient Content (%) | 1~5 | 3.02% | Pass | |
| Phosphorus pentoxide (P2O5) | Ingredient Content (%) | 3~4 | 3.53% | Pass | |
| Zirconium (hafnium) dioxide (Zr (Hf) O2) | Ingredient Content (%) | 0.5 ~ 6 | 1.86% | Pass | |
| Praseodymium oxide (Pr6O11) | Ingredient Content (%) | ≤5 | 1.66% | Pass | |
| Cerium dioxide (CeO2) | Ingredient Content (%) | ≤2.5 | 1.61% | Pass | |
| Erbium oxide (Er2O3) | Ingredient Content (%) | ≤4.5 | 1.59% | Pass | |
| Manganese dioxide (MnO2) | Ingredient Content (%) | ≤1 |
§ 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.