LS Block
LS Block is a preformed lithium disilicate dental ceramic block for producing crowns, veneers, inlays and onlays. The rainbow LS Block material is milled to the required restoration core…
LS Block is a preformed lithium disilicate dental ceramic block for producing crowns, veneers, inlays and onlays. The rainbow LS Block material is milled to the required restoration core shape and fired in a furnace to harden the ceramic.
Porcelain can then be layered over the fired core to complete the restoration. The block provides a machinable starting form for individualized dental work and is supplied nonsterile.
Restoration Scope
The stated applications are individual crowns, veneers, inlays and onlays. Anterior bridges are outside this product’s intended use. The principal ceramic chemistry is based on silica and lithium compounds, with other constituents modifying the material properties.
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) | K160144 |
| 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 | Length 12 to 15 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LBC14A2 | Length 15 mm | In distribution |
| LBI12B1 | Length 12 mm | In distribution |
| LBI12B2 | Length 12 mm | In distribution |
| LBC14A4 | Length 15 mm | In distribution |
| LBI12A3 | Length 12 mm | In distribution |
| LBI12B3 | Length 12 mm | In distribution |
| LBC14B1 | Length 15 mm | In distribution |
| LBC14A1 | Length 15 mm | In distribution |
| LBI12A4 | Length 12 mm | In distribution |
| LBI12A1 | Length 12 mm | In distribution |
| LBC14A3.5 | Length 15 mm | In distribution |
| LBI12A3.5 | Length 12 mm | In distribution |
| LBC14A3 | Length 15 mm | In distribution |
| LBI12B4 | Length 12 mm | In distribution |
| LBC14B2 | Length 15 mm | In distribution |
| LBI12A2 | Length 12 mm | In distribution |
| LBC14B3 | Length 15 mm | In distribution |
| LBC14B4 | Length 15 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.