DD Cubex² ML
51 catalogue numbers from 98H18 A1, listed by Dental Direkt GmbH, Germany, under Powder, Porcelain. 33 manufacturers in China are registered for this product code.
33manufacturers in China registered for this device type
51catalogue numbers in this listing
5510(k) clearances naming this product code
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 | 2017-02-21 |
| 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 | Outer diameter 98.5 mm; height 14 to 22 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 98H18 A1 | Outer Diameter 98.5 mm | In distribution |
| 98H14 A1 | Outer Diameter 98.5 mm | In distribution |
| 98H14 A2 | Height 14 mm | In distribution |
| 98H18 C2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 C4 | Height 18 mm | In distribution |
| 98H18 A2 | Outer Diameter 98.5 mm | In distribution |
| 98H14 D4 | Height 14 mm | In distribution |
| 98H18 A3 | Height 18 mm | In distribution |
| 98H14 Bleach | Height 14 mm | In distribution |
| 98H22 C4 | Height 22 mm | In distribution |
| 98H22 A2 | Height 22 mm | In distribution |
| 98H18 B3 | Height 18 mm | In distribution |
| 98H22 B3 | Height 22 mm | In distribution |
| 98H22 A1 | Height 22 mm | In distribution |
| 98H14 B1 | Outer Diameter 98.5 mm | In distribution |
| 98H22 Bleach | Height 22 mm | In distribution |
| 98H22 D3 | Outer Diameter 98.5 mm | In distribution |
| 98H14 B3 | Height 14 mm | In distribution |
| 98H14 D3 | Height 14 mm | In distribution |
| 98H18 B2 | Height 18 mm | In distribution |
| 98H14 A3.5 | Height 14 mm | In distribution |
| 98H14 C1 | Height 14 mm | In distribution |
| 98H18 D4 | Height 18 mm | In distribution |
| 98H14 D2 | Height 14 mm | In distribution |
| 98H22 B4 | Height 22 mm | In distribution |
| 98H14 C4 | Height 14 mm | In distribution |
| 98H14 B2 | Height 14 mm | In distribution |
| 98H18 Bleach | Height 18 mm | In distribution |
| 98H18 B4 | Height 18 mm | In distribution |
| 98H22 D2 | Height 22 mm | In distribution |
| 98H22 B2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 A3.5 | Outer Diameter 98.5 mm | In distribution |
| 98H14 A3 | Outer Diameter 98.5 mm | In distribution |
| 98H22 D4 | Height 22 mm | In distribution |
| 98H18 A4 | Height 18 mm | In distribution |
| 98H14 C3 | Height 14 mm | In distribution |
| 98H22 A4 | Height 22 mm | In distribution |
| 98H22 C3 | Height 22 mm | In distribution |
| 98H14 B4 | Height 14 mm | In distribution |
| 98H18 C1 | Height 18 mm | In distribution |
| 98H18 C3 | Height 18 mm | In distribution |
| 98H22 C1 | Height 22 mm | In distribution |
| 98H22 C2 | Height 22 mm | In distribution |
| 98H22 B1 | Height 22 mm | In distribution |
| 98H14 A4 | Height 14 mm | In distribution |
| 98H14 C2 | Outer Diameter 98.5 mm | In distribution |
| 98H22 A3.5 | Height 22 mm | In distribution |
| 98H18 D3 | Height 18 mm | In distribution |
| 98H22 A3 | Outer Diameter 98.5 mm | In distribution |
| 98H18 D2 | Height 18 mm | In distribution |
| 98H18 B1 | 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.