Universal Speed
175 catalogue numbers from W ML UVS BL2 12, listed by U&C International Co., Ltd., South Korea, under Powder, Porcelain. 33 manufacturers in China are registered for this product code.
33manufacturers in China registered for this device type
175catalogue numbers in this listing
1510(k) clearance
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 | U&C International Co., Ltd., South Korea |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Manufacturer |
| 510(k) | K191902 |
| Record published | 2023-03-03 |
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 |
|---|---|---|
| W ML UVS BL2 12 | In distribution | |
| W ML UVS A3 14 | In distribution | |
| W ML UVS BL2 18 | In distribution | |
| W ML UVS D3 14 | In distribution | |
| W ML UVS A2 10 | In distribution | |
| W ML UVS BL3 18 | In distribution | |
| W ML UVS A4 22 | In distribution | |
| W ML UVS B3 18 | In distribution | |
| W ML UVS C1 28 | In distribution | |
| W ML UVS A4 20 | In distribution | |
| W ML UVS B4 12 | In distribution | |
| W ML UVS C1 16 | In distribution | |
| W ML UVS C3 25 | In distribution | |
| W ML UVS B4 30 | In distribution | |
| W ML UVS B1 18 | In distribution | |
| W ML UVS BL3 20 | In distribution | |
| W ML UVS C4 20 | In distribution | |
| W ML UVS A2 14 | In distribution | |
| W ML UVS D3 22 | In distribution | |
| W ML UVS B3 20 | In distribution | |
| W ML UVS C1 25 | In distribution | |
| W ML UVS B4 16 | In distribution | |
| W ML UVS A1 12 | In distribution | |
| W ML UVS D3 20 | In distribution | |
| W ML UVS A3.5 16 | In distribution | |
| W ML UVS A3 28 | In distribution | |
| W ML UVS B3 28 | In distribution | |
| W ML UVS BL2 25 | In distribution | |
| W ML UVS B2 18 | In distribution | |
| W ML UVS B3 16 | In distribution | |
| W ML UVS C4 16 | In distribution | |
| W ML UVS A2 25 | In distribution | |
| W ML UVS A3.5 22 | In distribution | |
| W ML UVS D2 20 | In distribution | |
| W ML UVS D2 22 | In distribution | |
| W ML UVS D4 12 | In distribution | |
| W ML UVS A2 22 | In distribution | |
| W ML UVS C3 30 | In distribution | |
| W ML UVS C2 18 | In distribution | |
| W ML UVS B3 12 | In distribution | |
| W ML UVS B3 22 | In distribution | |
| W ML UVS D2 18 | In distribution | |
| W ML UVS BL3 28 | In distribution | |
| W ML UVS C2 16 | In distribution | |
| W ML UVS C1 20 | In distribution | |
| W ML UVS C2 25 | In distribution | |
| W ML UVS C3 14 | In distribution | |
| W ML UVS C3 12 | In distribution | |
| W ML UVS B2 30 | In distribution | |
| W ML UVS BL1 28 | In distribution | |
| W ML UVS D3 28 | In distribution | |
| W ML UVS A3 22 | In distribution | |
| W ML UVS A3.5 28 | In distribution | |
| W ML UVS BL1 16 | In distribution | |
| W ML UVS C4 28 | In distribution | |
| W ML UVS B3 25 | In distribution | |
| W ML UVS A3.5 30 | In distribution | |
| W ML UVS D4 14 | In distribution | |
| W ML UVS A1 16 | In distribution | |
| W ML UVS D3 12 | In distribution | |
| W ML UVS B2 20 | In distribution | |
| W ML UVS A4 12 | In distribution | |
| W ML UVS B1 30 | In distribution | |
| W ML UVS D3 16 | In distribution | |
| W ML UVS A3 12 | In distribution | |
| W ML UVS C1 22 | In distribution | |
| W ML UVS A3.5 18 | In distribution | |
| W ML UVS B4 14 | In distribution | |
| W ML UVS BL3 22 | In distribution | |
| W ML UVS BL1 12 | In distribution | |
| W ML UVS A2 30 | In distribution | |
| W ML UVS B1 20 | In distribution | |
| W ML UVS A3 25 | In distribution | |
| W ML UVS D2 28 | In distribution | |
| W ML UVS D4 25 | In distribution | |
| W ML UVS B1 12 | In distribution | |
| W ML UVS D3 30 | In distribution | |
| W ML UVS BL2 16 | In distribution | |
| W ML UVS C4 12 | In distribution | |
| W ML UVS A1 22 | In distribution | |
| W ML UVS BL2 30 | In distribution | |
| W ML UVS BL3 12 | In distribution | |
| W ML UVS D2 12 | In distribution | |
| W ML UVS D2 30 | In distribution | |
| W ML UVS C1 12 | In distribution | |
| W ML UVS A1 14 | In distribution | |
| W ML UVS BL1 30 | In distribution | |
| W ML UVS A1 20 | In distribution | |
| W ML UVS B1 28 | In distribution | |
| W ML UVS C1 18 | In distribution | |
| W ML UVS C2 20 | In distribution | |
| W ML UVS A3 30 | In distribution | |
| W ML UVS C4 25 | In distribution | |
| W ML UVS A1 28 | In distribution | |
| W ML UVS D2 16 | In distribution | |
| W ML UVS D4 30 | In distribution | |
| W ML UVS B4 20 | In distribution | |
| W ML UVS B1 22 | In distribution | |
| W ML UVS A4 30 | In distribution | |
| W ML UVS A4 25 | In distribution | |
| W ML UVS BL3 14 | In distribution | |
| W ML UVS BL1 20 | In distribution | |
| W ML UVS BL1 18 | In distribution | |
| W ML UVS BL1 22 | In distribution | |
| W ML UVS B2 16 | In distribution | |
| W ML UVS BL1 14 | In distribution | |
| W ML UVS C2 28 | In distribution | |
| W ML UVS D2 25 | In distribution | |
| W ML UVS D4 18 | In distribution | |
| W ML UVS A2 12 | In distribution | |
| W ML UVS D4 22 | In distribution | |
| W ML UVS C3 16 | In distribution | |
| W ML UVS A2 20 | In distribution | |
| W ML UVS C2 22 | In distribution | |
| W ML UVS BL3 30 | In distribution | |
| W ML UVS A3 18 | In distribution | |
| W ML UVS A1 25 | In distribution | |
| W ML UVS A4 18 | In distribution | |
| W ML UVS A3 10 | In distribution | |
| W ML UVS B1 25 | In distribution | |
| W ML UVS B4 22 | In distribution | |
| W ML UVS B2 14 | In distribution | |
| W ML UVS A3 16 | In distribution | |
| W ML UVS B3 30 | In distribution | |
| W ML UVS C3 22 | In distribution | |
| W ML UVS C3 20 | In distribution | |
| W ML UVS C4 18 | In distribution | |
| W ML UVS BL2 14 | In distribution | |
| W ML UVS BL3 25 | In distribution | |
| W ML UVS D3 25 | In distribution | |
| W ML UVS C3 28 | In distribution | |
| W ML UVS A4 14 | In distribution | |
| W ML UVS C2 30 | In distribution | |
| W ML UVS B1 16 | In distribution | |
| W ML UVS B1 14 | In distribution | |
| W ML UVS C1 30 | In distribution | |
| W ML UVS B3 14 | In distribution | |
| W ML UVS B4 18 | In distribution | |
| W ML UVS C4 22 | In distribution | |
| W ML UVS A1 30 | In distribution | |
| W ML UVS A3 20 | In distribution | |
| W ML UVS A3.5 12 | In distribution | |
| W ML UVS C4 30 | In distribution | |
| W ML UVS A3.5 25 | In distribution | |
| W ML UVS D4 20 | In distribution | |
| W ML UVS A3.5 10 | In distribution | |
| W ML UVS B4 28 | In distribution | |
| W ML UVS A4 28 | In distribution | |
| W ML UVS B2 22 | In distribution | |
| W ML UVS BL3 16 | In distribution | |
| W ML UVS C2 12 | In distribution | |
| W ML UVS A4 16 | In distribution | |
| W ML UVS BL2 20 | In distribution | |
| W ML UVS A1 18 | In distribution | |
| W ML UVS C2 14 | In distribution | |
| W ML UVS C3 18 | In distribution | |
| W ML UVS D3 18 | In distribution | |
| W ML UVS BL1 25 | In distribution | |
| W ML UVS B4 25 | In distribution | |
| W ML UVS B2 12 | In distribution | |
| W ML UVS A3.5 14 | In distribution | |
| W ML UVS D2 14 | In distribution | |
| W ML UVS BL2 28 | In distribution | |
| W ML UVS A3.5 20 | In distribution | |
| W ML UVS C1 14 | In distribution | |
| W ML UVS A2 28 | In distribution | |
| W ML UVS A1 10 | In distribution | |
| W ML UVS A2 18 | In distribution | |
| W ML UVS B2 28 | In distribution | |
| W ML UVS A2 16 | In distribution | |
| W ML UVS C4 14 | In distribution | |
| W ML UVS D4 28 | In distribution | |
| W ML UVS B2 25 | In distribution | |
| W ML UVS D4 16 | In distribution | |
| W ML UVS BL2 22 | 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 |
|---|---|
| K191902 | 2019-10-11 |
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.