Everest / Megabio Rainbow
562 catalogue numbers from W ML PT BL3 28, 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
562catalogue 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 | 2022-02-28 |
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 PT BL3 28 | In distribution | |
| W ML AT+ BL2 14 | In distribution | |
| Z ML AT A1 12 | In distribution | |
| W ML AT+ B2 28 | In distribution | |
| W ML PT BL1 14 | In distribution | |
| Z ML PT A4 20 | In distribution | |
| W ML AT+ A2 25 | In distribution | |
| W ML AT+ BL3 25 | In distribution | |
| W ML PT BL1 22 | In distribution | |
| W ML AT D2 14 | In distribution | |
| W ML AT D3 12 | In distribution | |
| W ML AT B3 18 | In distribution | |
| Z ML AT A2 30 | In distribution | |
| W ML AT D2 18 | In distribution | |
| Z ML PT A3.5 22 | In distribution | |
| Z ML PT A3.5 14 | In distribution | |
| W ML PT C4 28 | In distribution | |
| W ML AT B4 12 | In distribution | |
| W ML PT C3 28 | In distribution | |
| W ML AT BL2 10 | In distribution | |
| W ML PT D3 20 | In distribution | |
| W ML PT B3 18 | In distribution | |
| W ML AT+ B3 16 | In distribution | |
| W ML AT+ B2 18 | In distribution | |
| W ML PT B3 14 | In distribution | |
| W ML AT BL2 20 | In distribution | |
| W ML AT BL2 16 | In distribution | |
| W ML PT C1 20 | In distribution | |
| W ML PT D2 28 | In distribution | |
| W ML AT+ A2 16 | In distribution | |
| W ML AT+ A1 14 | In distribution | |
| W ML PT B2 25 | In distribution | |
| W ML PT B4 12 | In distribution | |
| W ML PT C2 12 | In distribution | |
| W ML AT+ B3 30 | In distribution | |
| W ML AT+ C4 25 | In distribution | |
| Z ML PT A1 12 | In distribution | |
| W ML AT A1 28 | In distribution | |
| W ML AT+ BL3 18 | In distribution | |
| W ML AT+ C3 25 | In distribution | |
| Z ML AT A3.5 30 | In distribution | |
| Z ML PT A3.5 25 | In distribution | |
| W ML AT BL1 25 | In distribution | |
| Z ML PT A3.5 20 | In distribution | |
| W ML AT+ B2 20 | In distribution | |
| W ML AT+ C3 20 | In distribution | |
| W ML AT+ C1 28 | In distribution | |
| W ML PT A3.5 30 | In distribution | |
| W ML AT B3 28 | In distribution | |
| W ML AT+ BL2 10 | In distribution | |
| Z ML AT A4 20 | In distribution | |
| W ML AT D2 12 | In distribution | |
| Z ML PT A3 28 | In distribution | |
| Z ML AT A2 20 | In distribution | |
| W ML AT A4 28 | In distribution | |
| W ML AT BL0 16 | In distribution | |
| W ML AT C4 18 | In distribution | |
| W ML AT C4 14 | In distribution | |
| W ML AT BL3 28 | In distribution | |
| W ML AT BL3 25 | In distribution | |
| W ML PT B4 22 | In distribution | |
| W ML AT+ D3 12 | In distribution | |
| W ML AT+ C4 12 | In distribution | |
| Z ML AT A3.5 14 | In distribution | |
| W ML AT B3 12 | In distribution | |
| W ML AT+ A2 12 | In distribution | |
| W ML AT C2 22 | In distribution | |
| W ML AT+ A3 18 | In distribution | |
| W ML PT C2 20 | In distribution | |
| W ML AT+ D2 12 | In distribution | |
| W ML AT BL2 14 | In distribution | |
| W ML AT B4 20 | In distribution | |
| Z ML AT A1 30 | In distribution | |
| W ML AT C4 20 | In distribution | |
| W ML PT BL1 18 | In distribution | |
| Z ML PT A2 18 | In distribution | |
| W ML AT+ B1 30 | In distribution | |
| W ML PT C3 14 | In distribution | |
| Z ML AT A2 16 | In distribution | |
| W ML AT+ A1 20 | In distribution | |
| W ML AT BL1 30 | In distribution | |
| Z ML AT A1 18 | In distribution | |
| W ML PT BL2 12 | In distribution | |
| W ML AT+ C4 18 | In distribution | |
| W ML AT C2 12 | In distribution | |
| W ML AT C2 25 | In distribution | |
| W ML PT A3 28 | In distribution | |
| Z ML AT A3 25 | In distribution | |
| W ML AT D4 12 | In distribution | |
| W ML AT+ D4 14 | In distribution | |
| W ML AT BL3 16 | In distribution | |
| W ML AT+ C2 22 | In distribution | |
| W ML AT+ BL2 28 | In distribution | |
| Z ML PT A2 22 | In distribution | |
| W ML AT+ D2 18 | In distribution | |
| Z ML PT A3 22 | In distribution | |
| W ML AT D3 16 | In distribution | |
| W ML PT B1 22 | In distribution | |
| W ML PT B2 22 | In distribution | |
| W ML AT B4 18 | In distribution | |
| Z ML AT A2 28 | In distribution | |
| Z ML AT A3 16 | In distribution | |
| W ML AT B1 12 | In distribution | |
| W ML AT BL2 25 | In distribution | |
| W ML AT D2 30 | In distribution | |
| W ML AT B2 28 | In distribution | |
| W ML PT A2 28 | In distribution | |
| W ML PT D3 30 | In distribution | |
| W ML PT B1 25 | In distribution | |
| W ML AT+ A3.5 28 | In distribution | |
| Z ML PT A2 25 | In distribution | |
| W ML AT+ BL3 30 | In distribution | |
| W ML PT C3 22 | In distribution | |
| Z ML PT A4 25 | In distribution | |
| W ML AT C2 20 | In distribution | |
| W ML AT+ A2 18 | In distribution | |
| Z ML PT A1 16 | In distribution | |
| W ML AT C3 12 | In distribution | |
| W ML AT+ A2 20 | In distribution | |
| W ML AT C1 22 | In distribution | |
| W ML PT B1 18 | In distribution | |
| W ML AT C4 16 | In distribution | |
| W ML AT+ A3.5 14 | In distribution | |
| W ML PT C1 14 | In distribution | |
| W ML AT+ C3 30 | In distribution | |
| W ML AT BL2 18 | In distribution | |
| W ML AT A3 28 | In distribution | |
| W ML AT+ D4 22 | In distribution | |
| W ML PT BL3 12 | In distribution | |
| W ML AT B4 16 | In distribution | |
| Z ML PT A3 10 | In distribution | |
| W ML AT B4 14 | In distribution | |
| W ML AT A2 30 | In distribution | |
| W ML AT+ B1 22 | In distribution | |
| W ML PT BL2 10 | In distribution | |
| W ML PT D4 30 | In distribution | |
| Z ML PT A3.5 28 | In distribution | |
| W ML AT C1 18 | In distribution | |
| Z ML PT A2 12 | In distribution | |
| W ML AT B1 14 | In distribution | |
| W ML AT+ B3 28 | In distribution | |
| W ML PT D2 20 | In distribution | |
| W ML AT D4 16 | In distribution | |
| W ML AT+ B2 12 | In distribution | |
| W ML PT BL1 30 | In distribution | |
| Z ML AT A4 25 | In distribution | |
| W ML PT D4 20 | In distribution | |
| Z ML AT A3 20 | In distribution | |
| W ML AT+ B4 14 | In distribution | |
| W ML AT B1 28 | In distribution | |
| W ML AT+ A4 16 | In distribution | |
| Z ML AT A4 18 | In distribution | |
| W ML PT C4 14 | In distribution | |
| W ML PT B2 20 | In distribution | |
| W ML AT B3 30 | In distribution | |
| W ML AT+ D3 16 | In distribution | |
| W ML AT+ A4 28 | In distribution | |
| W ML AT A1 30 | In distribution | |
| W ML PT D3 28 | In distribution | |
| W ML PT C4 25 | In distribution | |
| W ML AT D3 20 | In distribution | |
| Z ML AT A3.5 22 | In distribution | |
| W ML AT+ B2 16 | In distribution | |
| W ML PT BL0 10 | In distribution | |
| W ML AT+ C1 25 | In distribution | |
| W ML AT+ A2 22 | In distribution | |
| W ML PT C2 28 | In distribution | |
| W ML AT+ B3 22 | In distribution | |
| W ML PT C4 30 | In distribution | |
| Z ML AT A4 30 | In distribution | |
| W ML PT C3 20 | In distribution | |
| W ML AT+ A1 18 | In distribution | |
| W ML AT BL0 18 | In distribution | |
| W ML AT B1 25 | In distribution | |
| W ML PT C2 25 | In distribution | |
| W ML PT BL2 20 | In distribution | |
| W ML AT+ B4 30 | In distribution | |
| W ML AT+ A2 28 | In distribution | |
| W ML AT C4 30 | In distribution | |
| W ML PT C1 12 | In distribution | |
| W ML AT+ A2 30 | In distribution | |
| Z ML PT A3 25 | In distribution | |
| W ML AT C1 28 | In distribution | |
| W ML PT A3 30 | In distribution | |
| Z ML AT A3 14 | In distribution | |
| W ML AT+ A3 14 | In distribution | |
| W ML PT B3 16 | In distribution | |
| W ML AT+ B1 28 | In distribution | |
| Z ML AT A3.5 16 | In distribution | |
| W ML PT B1 16 | In distribution | |
| W ML AT D3 28 | In distribution | |
| W ML AT B2 25 | In distribution | |
| W ML AT D3 14 | In distribution | |
| W ML AT C4 22 | In distribution | |
| W ML PT C2 22 | In distribution | |
| W ML AT+ D4 18 | In distribution | |
| Z ML PT A2 14 | In distribution | |
| W ML PT D2 12 | In distribution | |
| W ML AT C3 22 | In distribution | |
| W ML AT D4 25 | In distribution | |
| W ML PT C1 25 | In distribution | |
| W ML AT B2 14 | In distribution | |
| W ML PT A4 28 | In distribution | |
| W ML AT C4 25 | In distribution | |
| Z ML AT A3.5 20 | In distribution | |
| W ML AT BL2 22 | In distribution | |
| W ML AT+ A1 16 | In distribution | |
| W ML AT+ BL2 18 | In distribution | |
| W ML PT C3 25 | In distribution | |
| Z ML PT A2 28 | In distribution | |
| W ML AT B2 20 | In distribution | |
| W ML PT B2 12 | In distribution | |
| W ML AT+ D2 30 | In distribution | |
| W ML AT C2 16 | In distribution | |
| Z ML PT A4 10 | In distribution | |
| Z ML AT A2 25 | In distribution | |
| W ML PT BL0 16 | In distribution | |
| W ML AT+ BL1 30 | In distribution | |
| Z ML AT A3 28 | In distribution | |
| W ML PT D4 16 | In distribution | |
| W ML AT+ BL1 28 | In distribution | |
| Z ML AT A2 14 | In distribution | |
| W ML AT B2 18 | In distribution | |
| Z ML AT A3 12 | In distribution | |
| Z ML AT A3 10 | In distribution | |
| W ML AT+ D2 20 | In distribution | |
| W ML PT BL2 28 | In distribution | |
| Z ML AT A3.5 10 | In distribution | |
| Z ML PT A3 12 | In distribution | |
| W ML AT+ BL2 22 | In distribution | |
| W ML AT+ A3 12 | In distribution | |
| W ML AT+ BL2 30 | In distribution | |
| W ML AT C3 25 | In distribution | |
| W ML AT D3 18 | In distribution | |
| W ML PT B4 20 | In distribution | |
| W ML PT BL3 20 | In distribution | |
| Z ML AT A2 12 | In distribution | |
| W ML AT B1 30 | In distribution | |
| W ML AT+ A3.5 16 | In distribution | |
| W ML AT+ A4 18 | In distribution | |
| Z ML AT A2 18 | In distribution | |
| W ML AT D4 28 | In distribution | |
| W ML AT+ C3 18 | In distribution | |
| W ML AT+ C4 22 | In distribution | |
| W ML AT+ BL1 18 | In distribution | |
| Z ML PT A4 16 | In distribution | |
| W ML AT D4 14 | In distribution | |
| Z ML PT A1 28 | In distribution | |
| W ML PT BL1 12 | In distribution | |
| W ML PT D2 25 | 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.