DD Cubex²
DD cubeX² is a presintered zirconia blank for making dental crowns and bridge frameworks with up to three units in the front or back of the mouth. Dental laboratories shape the blank using…
DD cubeX² is a presintered zirconia blank for making dental crowns and bridge frameworks with up to three units in the front or back of the mouth. Dental laboratories shape the blank using commercial CAD/CAM equipment or a hand-operated copy-milling machine.
The ceramic is zirconium dioxide stabilized with yttrium oxide. Its formulation promotes a cubic zirconia phase associated with translucency.
Colouring and Finishing
DD Bio ZX2 monolith zero colouring liquid is an accessory for the zirconia restorations. The restoration is coloured and then sintered as part of its fabrication.
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 | Dental Direkt GmbH, Germany |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K150196 |
| Record published | 2017-01-12 |
| Record revised | 2025-12-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 10 to 25 mm; outer diameter 95 to 98.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 95H22 | Height 22 mm | In distribution |
| 95H25 | Height 25 mm | In distribution |
| 95H18 | Height 18 mm | In distribution |
| 98H10 | Height 10 mm | In distribution |
| 98H16 | Outer Diameter 98.5 mm | In distribution |
| 98H18 | Outer Diameter 98.5 mm | In distribution |
| 95H14 | Height 14 mm | In distribution |
| 98H25 | Outer Diameter 98.5 mm | In distribution |
| 98H12 | Outer Diameter 98.5 mm | In distribution |
| 95H10 | Height 10 mm | In distribution |
| 98H14 | Height 14 mm | In distribution |
| 98H20 | Outer Diameter 98.5 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 |
|---|---|
| K241579 | 2024-09-06 |
| K193588 | 2020-04-16 |
| K183569 | 2019-02-14 |
| K170885 | 2017-08-01 |
| K150196 | 2015-03-26 |
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.