DD Art Elements
DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered white zirconia constructions made from DD Bio Z, DD Bio ZX² or DD cubeX² zirconia milling…
DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered white zirconia constructions made from DD Bio Z, DD Bio ZX² or DD cubeX² zirconia milling blanks for the manufacture of dental restorations.
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 | 2016-11-09 |
| Record revised | 2025-12-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Total volume 15 to 100 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SC1 | Total Volume 15 ml | In distribution | |
| light pink | Total Volume 30 ml | In distribution | |
| SA2 | Total Volume 15 ml | In distribution | |
| Vario | Total Volume 100 ml | In distribution | |
| Vario | Total Volume 30 ml | In distribution | |
| light brown | Total Volume 30 ml | In distribution | |
| SA1 | In distribution | ||
| dark grey | Total Volume 30 ml | In distribution | |
| graphit | Total Volume 30 ml | In distribution | |
| light grey | Total Volume 30 ml | In distribution | |
| Set | 16 | In distribution | |
| SC2 | Total Volume 15 ml | In distribution | |
| SO | Total Volume 15 ml | In distribution | |
| blue | Total Volume 30 ml | In distribution | |
| orange | Total Volume 30 ml | In distribution | |
| purple | Total Volume 30 ml | In distribution | |
| SO bright | Total Volume 15 ml | In distribution | |
| dark brown | Total Volume 30 ml | In distribution | |
| yellow | Total Volume 30 ml | In distribution | |
| dark pink | Total Volume 30 ml | 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.