DD Bio ZX² Color
„ DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. DD Bio ZX² can be used for all dental constructions with up to two bridge elements…
„ DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. DD Bio ZX² can be used for all dental constructions with up to two bridge elements in the front and side tooth area.
33manufacturers in China registered for this device type
121catalogue 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) | K142987 |
| Record published | 2016-10-05 |
| Record revised | 2025-12-11 (version 5) |
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 71 to 98.5 mm |
| Distribution end date | 2025-12-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 98H20 D4 | Outer Diameter 98.5 mm | In distribution |
| 98H25 D2 | Outer Diameter 98.5 mm | In distribution |
| 98H25 A2 | Outer Diameter 98.5 mm | In distribution |
| 98H25 D4 | Outer Diameter 98.5 mm | In distribution |
| 98H25 B2 | Outer Diameter 98.5 mm | In distribution |
| 98H12 A2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 B4 | Outer Diameter 98.5 mm | In distribution |
| 98H14 B1 | Outer Diameter 98.5 mm | In distribution |
| 98H10 C3 | Outer Diameter 98.5 mm | In distribution |
| 98H20 A2 | Outer Diameter 98.5 mm | In distribution |
| 98H10 C2 | Outer Diameter 98.5 mm | In distribution |
| 98H10 C4 | Outer Diameter 98.5 mm | In distribution |
| 98H25 A3.5 | Outer Diameter 98.5 mm | In distribution |
| 98H20 C4 | Outer Diameter 98.5 mm | In distribution |
| 98H10 A2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 B3 | Outer Diameter 98.5 mm | In distribution |
| 98H10 C1 | Outer Diameter 98.5 mm | In distribution |
| 98H14 B4 | Outer Diameter 98.5 mm | In distribution |
| 98H20 B1 | Outer Diameter 98.5 mm | In distribution |
| 98H14 C3 | Outer Diameter 98.5 mm | In distribution |
| 98H14 C1 | Outer Diameter 98.5 mm | In distribution |
| 98H18 C1 | Outer Diameter 98.5 mm | In distribution |
| 98H14 B3 | Outer Diameter 98.5 mm | In distribution |
| 98H25 C1 | Outer Diameter 98.5 mm | In distribution |
| 98H20 B2 | Height 20 mm | In distribution |
| 98H25 A1 | Height 25 mm | In distribution |
| 98H14 D3 | Outer Diameter 98.5 mm | In distribution |
| 98H14 A3 | Outer Diameter 98.5 mm | In distribution |
| 98H20 C3 | Outer Diameter 98.5 mm | In distribution |
| 98H10 B3 | Outer Diameter 98.5 mm | In distribution |
| 98H20 D2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 C2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 A4 | Outer Diameter 98.5 mm | In distribution |
| 98H10 D3 | Outer Diameter 98.5 mm | In distribution |
| 98H18 B2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 C4 | Outer Diameter 98.5 mm | In distribution |
| 98H14 C4 | Outer Diameter 98.5 mm | In distribution |
| 98H20 A4 | Outer Diameter 98.5 mm | In distribution |
| 98H14 A3.5 | Outer Diameter 98.5 mm | In distribution |
| 98H10 D4 | Outer Diameter 98.5 mm | In distribution |
| 98H20 A3 | Outer Diameter 98.5 mm | In distribution |
| 98H18 D2 | Outer Diameter 98.5 mm | In distribution |
| 98H25 C4 | Outer Diameter 98.5 mm | In distribution |
| 98H14 C2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 B1 | Outer Diameter 98.5 mm | In distribution |
| 98H20 B4 | Height 20 mm | In distribution |
| 98H10 A1 | Outer Diameter 98.5 mm | In distribution |
| 98H12 A3 | Outer Diameter 98.5 mm | In distribution |
| 98H25 C2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 C3 | Outer Diameter 98.5 mm | In distribution |
| 98H18 A1 | Outer Diameter 98.5 mm | In distribution |
| 98H25 C3 | Outer Diameter 98.5 mm | In distribution |
| 98H18 D3 | Height 18 mm | In distribution |
| 98H14 A2 | Outer Diameter 98.5 mm | In distribution |
| 98H10 D2 | Height 10 mm | In distribution |
| 98H25 B1 | In distribution | |
| 98H20 C2 | Outer Diameter 98.5 mm | In distribution |
| 98H20 D3 | Outer Diameter 98.5 mm | In distribution |
| 98H14 D4 | Outer Diameter 98.5 mm | In distribution |
| 98H25 A3 | In distribution | |
| 98H10 B1 | Outer Diameter 98.5 mm | In distribution |
| 98H10 B4 | Outer Diameter 98.5 mm | In distribution |
| 98H18 D4 | Outer Diameter 98.5 mm | In distribution |
| 98H25 A4 | In distribution | |
| 98H18 A2 | Outer Diameter 98.5 mm | In distribution |
| 98H10 A3 | Height 10 mm | In distribution |
| 98H14 B2 | Height 14 mm | In distribution |
| 98H25 B3 | Outer Diameter 98.5 mm | In distribution |
| 98H10 A3.5 | Outer Diameter 98.5 mm | In distribution |
| 98H25 D3 | Outer Diameter 98.5 mm | In distribution |
| 98H25 B4 | Outer Diameter 98.5 mm | In distribution |
| 98H14 A4 | Outer Diameter 98.5 mm | In distribution |
| 98H14 D2 | Outer Diameter 98.5 mm | In distribution |
| 98H10 B2 | Outer Diameter 98.5 mm | In distribution |
| 98H18 A3 | Outer Diameter 98.5 mm | In distribution |
| 98H10 A4 | Outer Diameter 98.5 mm | In distribution |
| 98H18 A1 | Outer Diameter 98.5 mm | In distribution |
| 98H20 C1 | Outer Diameter 98.5 mm | In distribution |
| 98H14 A1 | Outer Diameter 98.5 mm | In distribution |
| 98H20 A3.5 | Height 20 mm | In distribution |
| 98H18 A3.5 | Outer Diameter 98.5 mm | In distribution |
| 98H20 low chromatic | Outer Diameter 98.5 mm | Withdrawn |
| 71H14 low chromatic | Withdrawn | |
| 71H14 high chromatic | Height 14 mm | Withdrawn |
| 98H10 high chromatic | Outer Diameter 98.5 mm | Withdrawn |
| 98H25 medium | Outer Diameter 98.5 mm | Withdrawn |
| 71H14 light | Outer Diameter 71.0 mm | Withdrawn |
| 98H25 low chromatic | Outer Diameter 98.5 mm | Withdrawn |
| 98H10 intense | Outer Diameter 98.5 mm | Withdrawn |
| 71H16 light | Outer Diameter 71 mm | Withdrawn |
| 98H20 high chromatic | Outer Diameter 98.5 mm | Withdrawn |
| 71H20 medium | Outer Diameter 71 mm | Withdrawn |
| 71H14 intense | Outer Diameter 71 mm | Withdrawn |
| 71H16 intense | Outer Diameter 71 mm | Withdrawn |
| 98H25 high chromatic | Outer Diameter 98.5 mm | Withdrawn |
| 98H18 low chromatic | Outer Diameter 98.5 mm | Withdrawn |
| 98H18 medium | Outer Diameter 98.5 mm | Withdrawn |
| 98H18 intense | Height 18 mm | Withdrawn |
| 71H20 high chromatic | Outer Diameter 71 mm | Withdrawn |
| 98H10 medium | Withdrawn | |
| 71H20 light | Outer Diameter 71 mm | Withdrawn |
| 71H16 medium | Outer Diameter 71 mm | Withdrawn |
| 98H18 high chromatic | Outer Diameter 98.5 mm | Withdrawn |
| 98H20 intense | Outer Diameter 98.5 mm | Withdrawn |
| 71H14 medium | Outer Diameter 71 mm | Withdrawn |
| 98H14 high chromatic | Outer Diameter 98.5 mm | Withdrawn |
| 98H14 light | Outer Diameter 98.5 mm | Withdrawn |
| 98H20 light | Outer Diameter 98.5 mm | Withdrawn |
| 98H18 light | Outer Diameter 98.5 mm | Withdrawn |
| 71H16 low chromatic | Height 16 mm | Withdrawn |
| 71H20 low chromatic | Outer Diameter 71 mm | Withdrawn |
| 98H20 medium | Outer Diameter 98.5 mm | Withdrawn |
| 98H25 light | Outer Diameter 98.5 mm | Withdrawn |
| 98H14 intense | Outer Diameter 98.5 mm | Withdrawn |
| 98H14 medium | Outer Diameter 98.5 mm | Withdrawn |
| 98H10 light | Outer Diameter 98.5 mm | Withdrawn |
| 98H14 low chromatic | Outer Diameter 98.5 mm | Withdrawn |
| 98H10 low chromatic | Outer Diameter 98.5 mm | Withdrawn |
| 98H25 intense | Outer Diameter 98.5 mm | Withdrawn |
| 71H20 intense | Outer Diameter 71 mm | Withdrawn |
| 71H16 high chromatic | Outer Diameter 71 mm | Withdrawn |
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.