Rainbow Shade Block
Rainbow Shade is a presintered zirconia ceramic block used to fabricate single-tooth and bridge restorations. The colored block is a starting material that must be shaped and fired before…
Rainbow Shade is a presintered zirconia ceramic block used to fabricate single-tooth and bridge restorations. The colored block is a starting material that must be shaped and fired before it becomes a dental restoration. It is supplied nonsterile for professional dental fabrication.
A milling machine cuts the block into the required dental core. The core is then fired in a furnace to harden the zirconia. Porcelain is layered over that core to form the finished tooth or bridge restoration.
Material
The ceramic is yttria-stabilized tetragonal zirconia. The material is colored before fabrication, rather than being an unshaded block.
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) | K151844 |
| Record published | 2016-12-17 |
| Record revised | 2018-07-24 (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 | Width 98 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TS9822A1 | Width 98 mm | In distribution |
| TS9812WA05 | Width 98 mm | In distribution |
| TS9818WA1 | Width 98 mm | In distribution |
| TS9824A2 | Width 98 mm | In distribution |
| TS9824WA05 | Width 98 mm | In distribution |
| TS9814WA1 | Width 98 mm | In distribution |
| TS9818A2 | Width 98 mm | In distribution |
| TS9822A2 | Width 98 mm | In distribution |
| TS9816A2 | Width 98 mm | In distribution |
| TS9814A05 | Width 98 mm | In distribution |
| TS9810WA2 | Width 98 mm | In distribution |
| TS9812A2 | Width 98 mm | In distribution |
| TS9812WA2 | Width 98 mm | In distribution |
| TS9810WA05 | Width 98 mm | In distribution |
| TS9818WA2 | Width 98 mm | In distribution |
| TS9824WA2 | Width 98 mm | In distribution |
| TS9810WA1 | Width 98 mm | In distribution |
| TS9810A05 | Width 98 mm | In distribution |
| TS9814WA2 | Width 98 mm | In distribution |
| TS9820WA2 | Width 98 mm | In distribution |
| TS9822A05 | Width 98 mm | In distribution |
| TS9812WA1 | Width 98 mm | In distribution |
| TS9810A1 | Width 98 mm | In distribution |
| TS9820WA05 | Width 98 mm | In distribution |
| TS9824A05 | Width 98 mm | In distribution |
| TS9812A05 | Width 98 mm | In distribution |
| TS9816WA2 | Width 98 mm | In distribution |
| TS9820A1 | Width 98 mm | In distribution |
| TS9818A1 | Width 98 mm | In distribution |
| TS9818WA05 | Width 98 mm | In distribution |
| TS9814A1 | Width 98 mm | In distribution |
| TS9822WA1 | Width 98 mm | In distribution |
| TS9824A1 | Width 98 mm | In distribution |
| TS9814A2 | Width 98 mm | In distribution |
| TS9810A2 | Width 98 mm | In distribution |
| TS9820A05 | Width 98 mm | In distribution |
| TS9814WA05 | Width 98 mm | In distribution |
| TS9820WA1 | Width 98 mm | In distribution |
| TS9822WA2 | Width 98 mm | In distribution |
| TS9816A1 | Width 98 mm | In distribution |
| TS9816WA05 | Width 98 mm | In distribution |
| TS9812A1 | Width 98 mm | In distribution |
| TS9816A05 | Width 98 mm | In distribution |
| TS9820A2 | Width 98 mm | In distribution |
| TS9818A05 | Width 98 mm | In distribution |
| TS9822WA05 | Width 98 mm | In distribution |
| TS9824WA1 | Width 98 mm | In distribution |
| TS9816WA1 | Width 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.