Razor / MegaPlus
800 catalogue numbers from W 800 C1 10, 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
800catalogue 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 | 2022-02-16 |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| W 800 C1 10 | In distribution | ||
| W 1300 B1 22 | In distribution | ||
| W 800 C4 10 | In distribution | ||
| W 1300 A0 20 | In distribution | ||
| W 1300 D2 10 | In distribution | ||
| W 1300 C3 22 | In distribution | ||
| C 800 A1 B55 | 3 | In distribution | |
| W 1300 A2 12 | In distribution | ||
| W 1100 D4 14 | In distribution | ||
| W 800 B2 28 | In distribution | ||
| W 1100 A3 18 | In distribution | ||
| W 1100 ML 14 | In distribution | ||
| C 1100 ML A3 B55 | 2 | In distribution | |
| W 1100 A1 20 | In distribution | ||
| C 1100 A4 B55 | 4 | In distribution | |
| Z 1100 AB1 30 | In distribution | ||
| W 1100 A3 14 | In distribution | ||
| W 1100 B1 20 | In distribution | ||
| W 1300 A4 14 | In distribution | ||
| C 1100 A2 B85 | In distribution | ||
| W 1100 C1 14 | In distribution | ||
| W 1100 D3 28 | In distribution | ||
| C 1300 A2 B55 | 4 | In distribution | |
| W 800 C1 14 | In distribution | ||
| W 1300 A0 14 | In distribution | ||
| W 1100 D2 20 | In distribution | ||
| D 800 Dark 25 | In distribution | ||
| W 1300 A3.5 16 | In distribution | ||
| W 1300 A3.5 30 | In distribution | ||
| C 1300 A3 B65 | 2 | In distribution | |
| C 800 A4 B55 | 4 | In distribution | |
| Z 800 C2 18 | In distribution | ||
| W 1300 C1 20 | In distribution | ||
| W 1100 C1 22 | In distribution | ||
| W 1100 A3.5 14 | In distribution | ||
| W 1300 A1 16 | In distribution | ||
| W 1300 C2 30 | In distribution | ||
| Z 800 Dark 18 | In distribution | ||
| W 1100 C3 30 | In distribution | ||
| W 1300 A3 10 | In distribution | ||
| W 1300 A0 12 | In distribution | ||
| W 1300 A3.5 14 | In distribution | ||
| C 1300 A3 B65 | 3 | In distribution | |
| W 1300 D3 22 | In distribution | ||
| W 1100 ML 18 | In distribution | ||
| C 1100 A0 B65 | In distribution | ||
| W 800 C3 22 | In distribution | ||
| W 1100 A0 18 | In distribution | ||
| C 1100 A1 B85 | In distribution | ||
| W 800 C2 20 | In distribution | ||
| C 800 A4 B65 | 2 | In distribution | |
| W 1100 BL1 10 | In distribution | ||
| W 1100 D3 22 | In distribution | ||
| W 800 C1 20 | In distribution | ||
| C 800 A3 B55 | 2 | In distribution | |
| W 1100 B1 10 | In distribution | ||
| W 800 D3 14 | In distribution | ||
| W 800 A3 30 | In distribution | ||
| W 1100 A1 12 | In distribution | ||
| C 1300 A1 B55 | 4 | In distribution | |
| W 800 C3 20 | In distribution | ||
| W 1100 A3.5 25 | In distribution | ||
| W 1100 C2 20 | In distribution | ||
| W 800 D4 14 | In distribution | ||
| W 800 D4 12 | In distribution | ||
| W 800 Light 16 | In distribution | ||
| W 800 B4 28 | In distribution | ||
| W 1300 C1 12 | In distribution | ||
| C 1100 A4 B85 | In distribution | ||
| W 1100 D2 25 | In distribution | ||
| W 1300 D3 16 | In distribution | ||
| W 1100 B4 28 | In distribution | ||
| W 1300 B4 22 | In distribution | ||
| W 1300 ML 10 | In distribution | ||
| W 1300 A1 25 | In distribution | ||
| W 1300 A2 16 | In distribution | ||
| W 1300 A0 10 | In distribution | ||
| W 1100 A0 25 | In distribution | ||
| W 800 B1 16 | In distribution | ||
| W 1100 A0 10 | In distribution | ||
| C 1100 A3 B55 | 3 | In distribution | |
| C 1100 A4 B65 | 2 | In distribution | |
| C 800 A2 B40 | In distribution | ||
| W 1100 BL3 25 | In distribution | ||
| Z 1100 B1 25 | In distribution | ||
| Z 800 B2 14 | In distribution | ||
| W 1300 B1 25 | In distribution | ||
| W 1300 B1 28 | In distribution | ||
| W 1300 B2 25 | In distribution | ||
| W 800 B4 14 | In distribution | ||
| W 1100 BL1 25 | In distribution | ||
| W 1300 A3 12 | In distribution | ||
| C 1100 A4 B40 | In distribution | ||
| W 1100 A2 18 | In distribution | ||
| C 1300 A4 B65 | 3 | In distribution | |
| W ML PT B2 28 | In distribution | ||
| W 800 B2 16 | In distribution | ||
| Z 800 C1 18 | In distribution | ||
| W 800 A3.5 16 | In distribution | ||
| W 800 D2 30 | In distribution | ||
| W 1100 A0 35 | In distribution | ||
| Z 800 C1 14 | In distribution | ||
| W 800 D4 22 | In distribution | ||
| W 800 B1 12 | In distribution | ||
| W 1100 D4 28 | In distribution | ||
| W 1100 B3 28 | In distribution | ||
| C 800 A4 B55 | 3 | In distribution | |
| W 1300 ML 22 | In distribution | ||
| C 1300 A1 B65 | In distribution | ||
| W 1100 BL2 25 | In distribution | ||
| W 1300 ML 25 | In distribution | ||
| W 800 D2 10 | In distribution | ||
| C 1100 A3 B40 | In distribution | ||
| W 1100 A3.5 18 | In distribution | ||
| W 800 B3 20 | In distribution | ||
| W 800 Dark 10 | In distribution | ||
| C 800 A1 B65 | In distribution | ||
| C 800 ML A3 B55 | 2 | In distribution | |
| C 1300 A1 B85 | In distribution | ||
| W 1100 BL2 30 | In distribution | ||
| W 800 B1 25 | In distribution | ||
| C 1300 A0 B55 | 4 | In distribution | |
| W 800 Pure 20 | In distribution | ||
| W 1100 D4 30 | In distribution | ||
| W 1100 D3 25 | In distribution | ||
| C 1100 ML A2 B65 | 2 | In distribution | |
| C 800 A2 B55 | 4 | In distribution | |
| W 1300 A3.5 20 | In distribution | ||
| C 800 A1 B85 | In distribution | ||
| W 1100 C2 18 | In distribution | ||
| W 800 B1 18 | In distribution | ||
| W 1300 A3.5 18 | In distribution | ||
| W 800 B1 20 | In distribution | ||
| W 800 Pure 14 | In distribution | ||
| W 800 A3.5 22 | In distribution | ||
| W 1300 B2 18 | In distribution | ||
| C 1100 A2 B55 | 4 | In distribution | |
| C 1300 A4 B55 | In distribution | ||
| W 1100 BL2 12 | In distribution | ||
| C 1100 A2 B55 | In distribution | ||
| W 800 Pure 18 | In distribution | ||
| W 1300 A4 25 | In distribution | ||
| W 1300 A1 14 | In distribution | ||
| C 1300 A2 B55 | 3 | In distribution | |
| W 800 B4 20 | In distribution | ||
| W 1300 C4 12 | In distribution | ||
| W ML PT B3 30 | In distribution | ||
| W 1300 B4 28 | In distribution | ||
| W 1100 ML 20 | In distribution | ||
| W 1100 AB1 35 | In distribution | ||
| C 1300 A2 B40 | 4 | In distribution | |
| W 1100 D2 16 | In distribution | ||
| C 1100 A1 B40 | In distribution | ||
| W 800 A0 12 | In distribution | ||
| W 800 C3 14 | In distribution | ||
| W 1100 B4 10 | In distribution | ||
| C 1300 A1 B40 | In distribution | ||
| W 1100 A0 20 | In distribution | ||
| D 800 Dark 18 | In distribution | ||
| W 800 D3 16 | In distribution | ||
| W 1300 C3 14 | In distribution | ||
| W 800 C1 22 | In distribution | ||
| C 1300 A0 B85 | In distribution | ||
| C 1300 A4 B40 | 4 | In distribution | |
| W 800 B4 16 | In distribution | ||
| W 800 Dark 22 | In distribution | ||
| W 1300 D4 20 | In distribution | ||
| C 1100 A3 B55 | 2 | In distribution | |
| W 1100 B4 12 | In distribution | ||
| W 800 D4 16 | In distribution | ||
| C 1100 ML A3 B55 | 4 | In distribution | |
| W 1100 ML 16 | In distribution | ||
| C 1100 ML B55 | 2 | In distribution | |
| W 800 B3 25 | In distribution | ||
| W ML PT C1 30 | In distribution | ||
| C 1100 A1 B55 | 2 | In distribution | |
| W 1300 D4 16 | In distribution | ||
| W 1300 C2 28 | In distribution | ||
| W 800 Dark 16 | In distribution | ||
| W 1100 C2 25 | In distribution | ||
| C 1300 A2 B55 | 2 | In distribution | |
| C 1300 A0 B65 | 3 | In distribution | |
| Z 1100 AB1 35 | In distribution | ||
| W 1100 D4 20 | In distribution | ||
| C 1300 ML B65 | 2 | In distribution | |
| C 800 A3 B65 | 2 | In distribution | |
| W 1100 A2 20 | In distribution | ||
| W 1100 D3 18 | In distribution | ||
| W 1300 C3 10 | In distribution | ||
| W 1300 B3 30 | In distribution | ||
| W 1100 C2 22 | In distribution | ||
| W 1300 C2 10 | In distribution | ||
| C 1300 A3 B55 | 2 | In distribution | |
| W 1100 BL3 35 | In distribution | ||
| C 1100 ML A3 B55 | In distribution | ||
| W 800 D4 20 | In distribution | ||
| W 1300 C1 25 | In distribution | ||
| W 1100 C2 10 | In distribution | ||
| C 1300 ML B40 | In distribution | ||
| W 1300 B1 14 | In distribution | ||
| W 800 B2 30 | In distribution | ||
| W 800 A3.5 28 | In distribution | ||
| C 800 ML B55 | In distribution | ||
| W 1300 C4 10 | In distribution | ||
| W 1300 B4 10 | In distribution | ||
| C 1300 ML B55 | 3 | In distribution | |
| C 800 A4 B55 | 2 | In distribution | |
| C 1100 ML B65 | 2 | In distribution | |
| W 1300 A4 12 | In distribution | ||
| W 1100 B4 16 | In distribution | ||
| D 800 Light 25 | In distribution | ||
| W 1100 C3 18 | In distribution | ||
| W 800 B1 30 | In distribution | ||
| W 800 C3 16 | In distribution | ||
| W 1300 C2 20 | In distribution | ||
| W 1300 A1 18 | In distribution | ||
| C 1300 A4 B85 | In distribution | ||
| D 800 Light 22 | In distribution | ||
| W 1100 A4 14 | In distribution | ||
| W 1300 B2 16 | In distribution | ||
| C 1100 ML A2 B55 | 4 | In distribution | |
| W 1100 A3.5 28 | In distribution | ||
| W 1100 BL1 22 | In distribution | ||
| W 1100 C2 16 | In distribution | ||
| Z 800 Light 18 | In distribution | ||
| W 800 C1 16 | In distribution | ||
| W 1300 C1 30 | In distribution | ||
| W 800 C3 10 | In distribution | ||
| W 1100 C1 28 | In distribution | ||
| C 800 ML A2 B55 | 3 | In distribution | |
| W 1300 A3 18 | In distribution | ||
| C 800 A0 B65 | 2 | In distribution | |
| C 1300 A1 B40 | 4 | In distribution | |
| W 800 D3 25 | In distribution | ||
| C 1100 A0 B40 | In distribution | ||
| W 1300 A3 16 | In distribution | ||
| W 1300 B2 14 | In distribution | ||
| W 1300 C2 18 | In distribution | ||
| Z 1100 BL2 25 | In distribution | ||
| W 800 D3 12 | In distribution | ||
| W 800 Pure 16 | In distribution | ||
| Z 1100 BL3 30 | In distribution | ||
| W 1100 B1 22 | In distribution | ||
| C 1100 A2 B40 | 4 | In distribution | |
| W 1300 B1 18 | In distribution | ||
| W 1300 C3 20 | In distribution | ||
| W 800 B3 30 | In distribution | ||
| W 800 Pure 12 | In distribution | ||
| W 1300 A4 16 | In distribution | ||
| W 800 D3 10 | In distribution |
Showing 250 of 300 catalogue numbers.
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.