DD Cube ONE ML
DD cube ONE ML is a multilayer, pre-sintered zirconia blank for making dental crowns and bridges. A dental milling process shapes the blank before final sintering develops the ceramic…
DD cube ONE ML is a multilayer, pre-sintered zirconia blank for making dental crowns and bridges. A dental milling process shapes the blank before final sintering develops the ceramic restoration.
The base is yttria-stabilized zirconia with small amounts of coloring oxides distributed through different layers. The upper layer contains fewer coloring oxides and is brighter, while the middle and lower layers provide progressively darker regions.
Listed Item
DD cube ONE® ML are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. DD cube ONE® ML can be used for all dental constructions incl. bridges greater than or equal to 4 units with up to two connected pontics in the front and side tooth area.
Built-In Shade Gradient
The layered blank is designed to produce a tooth-like shade directly after sintering. The gradient is part of the supplied material, so separate coloring liquids are not part of this multilayer configuration. The range supports anterior and posterior crown and bridge applications.
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) | K183569 |
| Record published | 2021-05-26 |
| Record revised | 2025-12-08 (version 2) |
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 14 to 22 mm; outer diameter 14 to 98.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 98H22 C4 | Height 22 mm | In distribution |
| 98H14 C2 | Outer Diameter 98.5 mm | In distribution |
| 98H22 B3 | Height 18 mm | In distribution |
| 98H22 A3.5 | Outer Diameter 98.5 mm | In distribution |
| 98H22 C2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 B4 | Height 18 mm | In distribution |
| 98H22 A2 | Outer Diameter 98.5 mm | In distribution |
| 98H14 C3 | Height 14 mm | In distribution |
| 98H22 B2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 A3 | Outer Diameter 98.5 mm | In distribution |
| 98H18 A4 | Height 18 mm | In distribution |
| 98H22 D4 | Height 22 mm | In distribution |
| 98H18 A1 | Outer Diameter 98.5 mm | In distribution |
| 98H18 C3 | Height 18 mm | In distribution |
| 98H14 D3 | Outer Diameter 98.5 mm | In distribution |
| 98H22 A3 | Outer Diameter 98.5 mm | In distribution |
| 98H14 D2 | Outer Diameter 14 mm | In distribution |
| 98H18 A2 | Outer Diameter 98.5 mm | In distribution |
| 98H22 D2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 C2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 D4 | Height 18 mm | In distribution |
| 98H18 C4 | Height 18 mm | In distribution |
| 98H14 B2 | Outer Diameter 98.5 mm | In distribution |
| 98H22 bleach | Outer Diameter 98.5 mm | In distribution |
| 98H14 A3 | Outer Diameter 98.5 mm | In distribution |
| 98H22 C3 | Height 22 mm | In distribution |
| 98H14 A4 | Height 14 mm | In distribution |
| 98H14 A1 | Outer Diameter 98.5 mm | In distribution |
| 98H18 D3 | Outer Diameter 98.5 mm | In distribution |
| 98H14 bleach | Outer Diameter 98.5 mm | In distribution |
| 98H14 C1 | Outer Diameter 98.5 mm | In distribution |
| 98H18 B1 | Outer Diameter 98.5 mm | In distribution |
| 98H14 B1 | Outer Diameter 98.5 mm | In distribution |
| 98H22 D3 | Outer Diameter 98.5 mm | In distribution |
| 98H14 B4 | Height 14 mm | In distribution |
| 98H18 A3.5 | Outer Diameter 98.5 mm | In distribution |
| 98H14 B3 | Height 14 mm | In distribution |
| 98H18 B2 | Outer Diameter 98.5 mm | In distribution |
| 98H14 C4 | Height 14 mm | In distribution |
| 98H14 A3.5 | Outer Diameter 98.5 mm | In distribution |
| 98H22 B4 | Height 22 mm | In distribution |
| 98H22 C1 | Outer Diameter 98.5 mm | In distribution |
| 98H14 A2 | Outer Diameter 98.5 mm | In distribution |
| 98H22 B1 | Outer Diameter 98.5 mm | In distribution |
| 98H18 bleach | Outer Diameter 98.5 mm | In distribution |
| 98H18 C1 | Outer Diameter 98.5 mm | In distribution |
| 98H18 D2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 B3 | Height 18 mm | In distribution |
| 98H14 D4 | Height 14 mm | In distribution |
| 98H22 A1 | Outer Diameter 98.5 mm | In distribution |
| 98H22 A4 | Height 22 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.