Rainbow Shine
Rainbow Shine is a partially sintered zirconia block used to make dental prostheses. It is milled to the planned shape by CAD/CAM or manual-aided machining and then sintered. The material…
Rainbow Shine is a partially sintered zirconia block used to make dental prostheses. It is milled to the planned shape by CAD/CAM or manual-aided machining and then sintered. The material is yttria-stabilized zirconia supplied as a preformed block.
The product is intended for manufacture of a dental core. Its ceramic classification is Type II, Class 5. The range offers blocks for single units and bridges, with different dimensions suited to the planned restoration.
Forms and Supply
Disk and stepped-block forms are included in the described range. Disks are offered in diameters of 87, 95, 98 or 100 mm and heights from 10 to 28 mm. The material is supplied nonsterile for prescription dental use.
Who Else Makes It
Concentrated in Guangdong (10), Hunan (6), Hebei (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| BMF Tech (Zhuhai) Inc. | Zhuhai | Guangdong | Contract manufacturer | 2 |
| Jiangxi Rekonova Dental Materials Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 1 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 11 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Shenzhen Yurucheng Dental Materials Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. | Zhangzhou | Henan | Manufacturer | 6 |
Showing 12 of 33. All 33 manufacturers in China registered for Powder, Porcelain
Record
| Listed by | Genoss Co., Ltd., South Korea |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Manufacturer |
| 510(k) | K160079 |
| Record published | 2017-12-20 |
| Record revised | 2022-06-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 1 to 30 °C |
| Sizes | Outer diameter 98 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SH9818WA0 | Outer Diameter 98 mm | In distribution |
| SH9812A2 | Outer Diameter 98 mm | In distribution |
| SH9810WA1 | Outer Diameter 98 mm | In distribution |
| SH9824A0 | Outer Diameter 98 mm | In distribution |
| SH9822WA1 | Outer Diameter 98 mm | In distribution |
| SH9810A1 | Outer Diameter 98 mm | In distribution |
| SH9812A0 | Outer Diameter 98 mm | In distribution |
| SH9820WA0 | Outer Diameter 98 mm | In distribution |
| SH9814A0 | Outer Diameter 98 mm | In distribution |
| SH9824WA2 | Outer Diameter 98 mm | In distribution |
| SH9820WA1 | Outer Diameter 98 mm | In distribution |
| SH9814A1 | Outer Diameter 98 mm | In distribution |
| SH9818A0 | Outer Diameter 98 mm | In distribution |
| SH9822WA2 | Outer Diameter 98 mm | In distribution |
| SH9824A2 | Outer Diameter 98 mm | In distribution |
| SH9822A2 | Outer Diameter 98 mm | In distribution |
| SH9810A2 | Outer Diameter 98 mm | In distribution |
| SH9818WA1 | Outer Diameter 98 mm | In distribution |
| SH9824A1 | Outer Diameter 98 mm | In distribution |
| SH9822A0 | Outer Diameter 98 mm | In distribution |
| SH9816A0 | Outer Diameter 98 mm | In distribution |
| SH9824WA0 | Outer Diameter 98 mm | In distribution |
| SH9820A0 | Outer Diameter 98 mm | In distribution |
| SH9812WA2 | Outer Diameter 98 mm | In distribution |
| SH9812WA0 | Outer Diameter 98 mm | In distribution |
| SH9816WA2 | Outer Diameter 98 mm | In distribution |
| SH9816A1 | Outer Diameter 98 mm | In distribution |
| SH9820WA2 | Outer Diameter 98 mm | In distribution |
| SH9810A0 | Outer Diameter 98 mm | In distribution |
| SH9812A1 | Outer Diameter 98 mm | In distribution |
| SH9824WA1 | Outer Diameter 98 mm | In distribution |
| SH9822WA0 | Outer Diameter 98 mm | In distribution |
| SH9818WA2 | Outer Diameter 98 mm | In distribution |
| SH9816A2 | Outer Diameter 98 mm | In distribution |
| SH9814WA2 | Outer Diameter 98 mm | In distribution |
| SH9822A1 | Outer Diameter 98 mm | In distribution |
| SH9812WA1 | Outer Diameter 98 mm | In distribution |
| SH9810WA2 | Outer Diameter 98 mm | In distribution |
| SH9810WA0 | Outer Diameter 98 mm | In distribution |
| SH9814A2 | Outer Diameter 98 mm | In distribution |
| SH9814WA0 | Outer Diameter 98 mm | In distribution |
| SH9818A2 | Outer Diameter 98 mm | In distribution |
| SH9816WA1 | Outer Diameter 98 mm | In distribution |
| SH9820A1 | Outer Diameter 98 mm | In distribution |
| SH9814WA1 | Outer Diameter 98 mm | In distribution |
| SH9820A2 | Outer Diameter 98 mm | In distribution |
| SH9816WA0 | Outer Diameter 98 mm | In distribution |
| SH9818A1 | Outer Diameter 98 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bloomden | Bloomden Bioceramics (Hunan) Co., Ltd. | 6,340 |
| Upcera Dental Zirconia Blank For Aesthetic Restoration | Liaoning Upcera Co., Ltd. | 4,367 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 4,310 |
| Luxen 5G | Dentalmax Co., Ltd. | 3,903 |
| GC Initial™ | GC America Inc. | 2,724 |
| Gradual Dental Zirconia Blank | Liaoning Upcera Co., Ltd. | 2,035 |
| Multi M Series | Dmax Co., Ltd. | 1,854 |
| Zirconia Dental Ceramics | Chengdu Besmile Medical Technology Co., Ltd. | 1,828 |
| Amber® Mill Q | Hass Corp. | 1,602 |
| Upcera Dental Zirconia Pre-Shaded Blank | Liaoning Upcera Co., Ltd. | 1,498 |
| BruxZir | Prismatik Dentalcraft, Inc. | 1,295 |
| ceraMotion® | Dentaurum GmbH & Co. KG | 1,062 |
Showing 12 of 10,017. All products under Powder, Porcelain
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233885 | 2024-06-21 |
| K232174 | 2024-02-23 |
| K160079 | 2016-11-10 |
| K160144 | 2016-07-21 |
| K151731 | 2016-04-15 |
| K151846 | 2016-01-14 |
| K151842 | 2016-01-14 |
| K151723 | 2015-10-28 |
| K151844 | 2015-10-16 |
| K092513 | 2009-10-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.