(191 days)
rainbow™ LS Pressing is used in the manufacture of Inlay, Onlay and Crown.
rainbow™ LS Pressing is a lithium disilicate glass-ceramic ingot for use with the press technique with similar strength and esthetics to natural tooth.
The provided document is a 510(k) Summary for a dental ceramic device, "rainbow™ LS Pressing." It outlines the device's characteristics and its substantial equivalence to a predicate device, IPS e.max Press and IPS e.max Press Multi. The document describes several non-clinical tests conducted to confirm the device's performance against established standards.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Predicate Device Performance (IPS e.max Press and IPS e.max Press Multi) | Subject Device Performance (rainbow™ LS Pressing) | Comparison/Conclusion |
|---|---|---|---|
| Bending Strength (ISO 6872:2008 for Class 3 dental ceramics: > 300 MPa) | 400 Mpa | 569 MPa | Subject device is higher than both predicate and required standard. |
| **Chemical Solubility (ISO 6872:2008 for Class 2 or 3 dental ceramics: |
§ 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.