KDF Zirconia Disc
KDF Zirconia Disc is a ceramic blank used by dental laboratories to make custom CAD/CAM restorations. Zirconium oxide forms the main material, with other oxides serving as stabilizers or…
KDF Zirconia Disc is a ceramic blank used by dental laboratories to make custom CAD/CAM restorations. Zirconium oxide forms the main material, with other oxides serving as stabilizers or colorants.
The range supports restorations for anterior and posterior teeth, including crowns, bridges, veneers, inlays and onlays. Shade families include Pure, MT and MU options.
Disc and Ceramic Classes
Discs have a 98.5 mm diameter, with thickness options from 10 to 35 mm. Under ISO 6872, the MU series is Type II, Class 4 ceramic, while the other listed series are Type II, Class 5. The ceramic classification therefore depends on the selected shade series.
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 | Denken-Highdental Co., Ltd., Japan |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K221429 |
| Record published | 2023-06-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MU-A1/30mm | In distribution | |
| MU-A1/25mm | In distribution | |
| MU-A2/20mm | In distribution | |
| MU-A1/16mm | In distribution | |
| MU-A1/20mm | In distribution | |
| MU-A2/22mm | In distribution | |
| MU-BL2/30mm | In distribution | |
| MU-A1/10mm | In distribution | |
| MU-A2/35mm | In distribution | |
| MU-A2/25mm | In distribution | |
| MU-A2/16mm | In distribution | |
| MU-A2/10mm | In distribution | |
| MU-BL2/35mm | In distribution | |
| MU-BL2/22mm | In distribution | |
| MU-A2/30mm | In distribution | |
| MU-BL2/16mm | In distribution | |
| MU-BL2/25mm | In distribution | |
| MU-A2/14mm | In distribution | |
| MU-A1/35mm | In distribution | |
| MU-BL2/20mm | In distribution | |
| MU-A1/18mm | In distribution | |
| MU-BL2/14mm | In distribution | |
| MU-A1/14mm | In distribution | |
| MU-A2/18mm | In distribution | |
| MU-A1/22mm | In distribution | |
| MU-BL2/10mm | In distribution | |
| MU-BL2/18mm | 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 |
|---|---|
| K221429 | 2022-07-14 |
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.