LS Pressing
Rainbow LS Pressing is a lithium disilicate glass-ceramic ingot for making dental inlays, onlays and crowns. Its preformed ingot supplies the ceramic material for the press technique used…
Rainbow LS Pressing is a lithium disilicate glass-ceramic ingot for making dental inlays, onlays and crowns. Its preformed ingot supplies the ceramic material for the press technique used to fabricate the restoration.
The material is based mainly on silica and lithium oxide, with additional constituents including calcium phosphate and other oxides. It is supplied nonsterile as a prescription dental material.
Ingot Form
The ingot is cylindrical, measuring 12.5 mm in diameter and 10 mm in height. This preformed format is intended for pressing rather than direct placement as a finished restoration; the laboratory fabrication process determines the final restoration shape.
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) | K151846 |
| Record published | 2018-07-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature 1 to 30 °C |
| Sizes | Outer diameter 12.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PIA3 | Outer Diameter 12.5 mm | In distribution |
| PIB2 | Outer Diameter 12.5 mm | In distribution |
| PIA4 | Outer Diameter 12.5 mm | In distribution |
| PIA1 | Outer Diameter 12.5 mm | In distribution |
| PIB4 | Outer Diameter 12.5 mm | In distribution |
| PIB1 | Outer Diameter 12.5 mm | In distribution |
| PIA3.5 | Outer Diameter 12.5 mm | In distribution |
| PIB3 | Outer Diameter 12.5 mm | In distribution |
| PIA2 | Outer Diameter 12.5 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.