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510(k) Data Aggregation
(301 days)
rainbow Shine
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.
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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 |
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(191 days)
Rainbow Shine
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) |
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