(301 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). These blanks are fabricated into dental core (zirconia substructure) of crowns and bridges. The core can be used as final prosthesis by itself or can be layered with porcelain. rainbow™ Shine is fabricated by CAD/CAM or MAD/MAM machining processes. At the dental lab, the blanks are held to the milling machine which is used to machine to the final dental restoration. After machining steps, the dental restoration is fully sintered in the furnace to harden the ZrO2. and fitted to the patients as crowns and bridges. rainbow™ Shine is available in numerous shapes and sizes in order to be compatible with multiple milling machines. According to the shapes, they are used for fabricating of each intended dental restoration, such as single crowns, bridges including from 2-bridge to 16bridge(full arch). It is also supplied in six different colors (A0, A0.5, A1, A2, A3, A4) for each shapes. rainbow™ Shine is not for use or intended for use to fabricate the top-half of an abutment/titanium base and is for the fabrication of dental restorations only.
This document is a 510(k) summary for the rainbow™ Shine dental ceramic. The document asserts the device's substantial equivalence to a predicate device based on non-clinical testing.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (ISO 6872:2008) | Reported Device Performance (rainbow™ Shine) | Reported Predicate Performance (rainbow™ High Shine) | Comparison to Acceptance Criteria |
|---|---|---|---|---|
| Bending Strength (Flexural Strength) | > 500 MPa (for Class 5 dental ceramics) | 865 MPa | 706 MPa | Meets and exceeds |
| Sintering Density | (Not explicitly stated in document, but "Same" for both devices implies meeting a standard) | 6 g/cm³ | 6 g/cm³ | Assumed to meet |
| Radioactivity |
§ 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.