(191 days)
rainbow™ Shine is used in the manufacture of a dental core through milling by machine (MAD/ MAM or CAD/CAM) followed by sintering.
rainbow™ Shine is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Shine is milled into cores of artificial teeth and then is finally sintered in a furnace to harden the ZrO2. Then, the core is layered with porcelain to make a finished tooth.
The provided document is a 510(k) summary for a dental ceramic device named "rainbow™ Shine". It details the device's characteristics and compares it to a predicate device, "RAINBOW BLOCK", to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate RAINBOW BLOCK / ISO 6872:2008) | Reported Device Performance (rainbow™ Shine) | Comparison Status / Notes |
|---|---|---|---|
| Device Classification | Type II - Class 6 (for predicate) | Type II - Class 5 | The subject device and predicate device satisfy dental ceramic classification requirements by ISO 6872:2008. The difference in class and bending strength is noted, with rainbow™ Shine having a lower bending strength due to complete Y2O3 stabilization for higher translucency. Despite this, it meets the ISO standard. |
| Bending Strength (Flexural strength) | 1144 MPa (for predicate) / > 500 MPa (ISO 6872:2008 for Class 5) | 706 MPa | Bending strength for rainbow™ Shine is higher than required by ISO 6872:2008 for Class 5 dental ceramics (> 500 MPa), despite being lower than the predicate. |
| Sintering Density (g/cm³) | 6.00-6.04 (for predicate) | 6 | Same (within range of predicate and likely meets ISO, though specific ISO density not stated) |
| Radioactivity (Bq/g) |
§ 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.