Everest / MegaPlus
451 catalogue numbers from W 1100 A2 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
451catalogue 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 | 2022-02-12 |
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 1100 A2 28 | In distribution | |
| D 1300 A2 20 | In distribution | |
| Z 1300 A1 12 | In distribution | |
| Z 800 A0 12 | In distribution | |
| Z 1300 A3 14 | In distribution | |
| W ML AT A2 22 | In distribution | |
| 5178 LT A2 98-25 | In distribution | |
| Z 1300 A4 25 | In distribution | |
| D 800 A4 12 | In distribution | |
| D 1100 A3 12 | In distribution | |
| 5168 HT WH 98-25 | In distribution | |
| 5187 LT WH 98-22 | In distribution | |
| Z 1100 A0 16 | In distribution | |
| D 800 A0 12 | In distribution | |
| Z 1100 A0 12 | In distribution | |
| Z 800 A0 10 | In distribution | |
| 5177 LT A2 98-22 | In distribution | |
| D 800 A1 14 | In distribution | |
| Z 800 A1 16 | In distribution | |
| W 800 ML 18 | In distribution | |
| W ML PT A3.5 25 | In distribution | |
| W 1100 A1 28 | In distribution | |
| D 1300 A1 18 | In distribution | |
| W ML AT A4 22 | In distribution | |
| W ML PT A2 16 | In distribution | |
| D 1300 A3 25 | In distribution | |
| D 1300 A4 12 | In distribution | |
| W ML PT A4 22 | In distribution | |
| W 800 A3 20 | In distribution | |
| W ML AT A1 25 | In distribution | |
| D 1300 A3 22 | In distribution | |
| W 800 A3 12 | In distribution | |
| D 800 A3 10 | In distribution | |
| D 800 A3 14 | In distribution | |
| Z 1300 ML 14 | In distribution | |
| D 1300 A0 10 | In distribution | |
| D 800 A1 12 | In distribution | |
| W 1100 A3 28 | In distribution | |
| D 1100 A0 25 | In distribution | |
| Z 1300 A4 20 | In distribution | |
| 5152 HT A2 98-12 | In distribution | |
| W ML PT A4 14 | In distribution | |
| D 1300 A1 12 | In distribution | |
| Z 1300 ML 10 | In distribution | |
| W 800 A1 10 | In distribution | |
| Z 1300 A2 16 | In distribution | |
| Z 800 A1 18 | In distribution | |
| D 1300 A4 18 | In distribution | |
| Z 800 ML 12 | In distribution | |
| D 800 A4 20 | In distribution | |
| 5157 HT A2 98-22 | In distribution | |
| D 1100 A3 22 | In distribution | |
| W 800 A1 14 | In distribution | |
| Z 1300 A4 14 | In distribution | |
| 5171 LT A2 98-10 | In distribution | |
| W 800 A2 12 | In distribution | |
| W ML PT A4 18 | In distribution | |
| D 1100 A2 10 | In distribution | |
| W 800 A2 16 | In distribution | |
| Z 1300 A2 14 | In distribution | |
| Z 1100 A3 10 | In distribution | |
| Z 1100 A2 14 | In distribution | |
| D 800 A2 20 | In distribution | |
| W 1100 A0 28 | In distribution | |
| D 1300 A2 10 | In distribution | |
| Z 1100 A3 14 | In distribution | |
| 5155 HT A2 98-18 | In distribution | |
| Z 1100 A3 16 | In distribution | |
| W 800 A3 14 | In distribution | |
| Z 1300 A3 25 | In distribution | |
| Z 800 A0 20 | In distribution | |
| D 1300 A4 14 | In distribution | |
| Z 1300 A1 22 | In distribution | |
| Z 1100 A4 20 | In distribution | |
| W ML PT A3.5 22 | In distribution | |
| W ML AT A3.5 25 | In distribution | |
| Z 1300 A1 25 | In distribution | |
| D 800 A3 16 | In distribution | |
| Z 1300 A4 16 | In distribution | |
| W ML AT A3 22 | In distribution | |
| Z 1300 A4 22 | In distribution | |
| W ML AT A3.5 22 | In distribution | |
| W 1100 A2 30 | In distribution | |
| 5154 HT A2 98-16 | In distribution | |
| Z 1100 A3 20 | In distribution | |
| Z 800 A2 25 | In distribution | |
| Z 800 A0 14 | In distribution | |
| W 800 A0 18 | In distribution | |
| D 1100 A0 16 | In distribution | |
| Z 800 A4 22 | In distribution | |
| D 1100 A4 14 | In distribution | |
| D 1300 A0 22 | In distribution | |
| Z 800 A1 22 | In distribution | |
| W 800 ML 22 | In distribution | |
| W MO A2 16 | In distribution | |
| D 800 A2 16 | In distribution | |
| Z 1100 A1 10 | In distribution | |
| W ML AT A3 10 | In distribution | |
| W ML AT A1 22 | In distribution | |
| D 1100 A3 25 | In distribution | |
| Z 1100 A4 22 | In distribution | |
| W ML PT A3.5 16 | In distribution | |
| D 1300 A1 16 | In distribution | |
| W 800 ML 20 | In distribution | |
| Z 800 A3 16 | In distribution | |
| D 1300 A0 20 | In distribution | |
| Z 1300 A2 25 | In distribution | |
| W 800 A1 12 | In distribution | |
| D 1300 A2 16 | In distribution | |
| Z 800 A4 25 | In distribution | |
| D 800 A1 18 | In distribution | |
| D 1300 A4 10 | In distribution | |
| W 800 A3 22 | In distribution | |
| Z 800 A3 12 | In distribution | |
| Z 1300 A2 10 | In distribution | |
| W ML AT A3 20 | In distribution | |
| D MO A2 20 | In distribution | |
| W ML PT A3.5 18 | In distribution | |
| W 800 A4 25 | In distribution | |
| Z 1300 A0 16 | In distribution | |
| D 800 A3 20 | In distribution | |
| Z 1100 ML 25 | In distribution | |
| Z 800 ML 18 | In distribution | |
| Z 1100 A0 14 | In distribution | |
| D 800 A1 20 | In distribution | |
| W ML PT A4 12 | In distribution | |
| Z 1100 A3 25 | In distribution | |
| W 1300 A2 30 | In distribution | |
| W 800 ML 12 | In distribution | |
| Z 1300 ML 25 | In distribution | |
| W MO A2 12 | In distribution | |
| Z 800 A2 16 | In distribution | |
| W 800 ML 16 | In distribution | |
| D 1100 A3 10 | In distribution | |
| W MO A2 10 | In distribution | |
| D 1300 A4 16 | In distribution | |
| Z 1300 A0 18 | In distribution | |
| D 800 A2 18 | In distribution | |
| W ML AT A3 16 | In distribution | |
| W ML PT A3 18 | In distribution | |
| D 1100 A4 16 | In distribution | |
| Z 1300 ML 18 | In distribution | |
| Z 1100 A0 25 | In distribution | |
| W ML PT A1 10 | In distribution | |
| D 1300 A0 14 | In distribution | |
| D 800 A1 16 | In distribution | |
| D 1300 A2 12 | In distribution | |
| W ML PT A3 12 | In distribution | |
| D MO A2 16 | In distribution | |
| 5162 HT WH 98-12 | In distribution | |
| W 800 A2 25 | In distribution | |
| 5174 LT A2 98-16 | In distribution | |
| Z 1100 ML 20 | In distribution | |
| W 800 A0 20 | In distribution | |
| W ML AT A3.5 12 | In distribution | |
| Z 1300 A1 10 | In distribution | |
| D 1300 A1 25 | In distribution | |
| Z 1300 A4 12 | In distribution | |
| D 1100 A2 25 | In distribution | |
| W 800 A4 16 | In distribution | |
| W ML PT A3 25 | In distribution | |
| W ML PT A3 20 | In distribution | |
| Z 1300 A0 22 | In distribution | |
| W 800 A4 22 | In distribution | |
| W 800 A4 20 | In distribution | |
| Z 1100 A3 12 | In distribution | |
| W 800 ML 14 | In distribution | |
| D 1100 A4 10 | In distribution | |
| Z 1300 ML 12 | In distribution | |
| W ML PT A1 12 | In distribution | |
| W MO A2 22 | In distribution | |
| D 1300 A3 16 | In distribution | |
| 5166 HT WH 98-20 | In distribution | |
| Z 800 A4 10 | In distribution | |
| 5176 LT A2 98-20 | In distribution | |
| Z 1100 A4 10 | In distribution | |
| W ML PT A3.5 12 | In distribution | |
| W ML PT A2 18 | In distribution | |
| 5184 LT WH 98-16 | In distribution | |
| D 800 A0 18 | In distribution | |
| W 800 ML 25 | In distribution | |
| D 1300 A3 18 | In distribution | |
| Z 800 ML 16 | In distribution | |
| W 1100 A0 30 | In distribution | |
| W ML PT A2 25 | In distribution | |
| W 800 A2 22 | In distribution | |
| 5186 LT WH 98-20 | In distribution | |
| D 1100 A0 18 | In distribution | |
| D 1100 A1 14 | In distribution | |
| W 800 A3 16 | In distribution | |
| Z 800 A1 14 | In distribution | |
| D 1100 A2 18 | In distribution | |
| W 1300 A2 28 | In distribution | |
| D 1100 A0 12 | In distribution | |
| D MO A2 25 | In distribution | |
| D 1100 A0 20 | In distribution | |
| D 1300 A3 20 | In distribution | |
| D 1100 A2 14 | In distribution | |
| Z 1300 A3 16 | In distribution | |
| D 800 A4 10 | In distribution | |
| Z 1100 A4 12 | In distribution | |
| Z 800 A1 12 | In distribution | |
| Z 1300 A3 18 | In distribution | |
| Z 800 A2 20 | In distribution | |
| D 1300 A0 18 | In distribution | |
| D MO A2 14 | In distribution | |
| Z 1100 A1 22 | In distribution | |
| D 800 A0 22 | In distribution | |
| W ML AT A3.5 20 | In distribution | |
| Z 1300 A3 22 | In distribution | |
| 5172 LT A2 98-12 | In distribution | |
| D 800 A3 22 | In distribution | |
| W ML PT A3.5 10 | In distribution | |
| Z 1300 A1 16 | In distribution | |
| Z 1300 ML 16 | In distribution | |
| Z 800 A0 25 | In distribution | |
| Z 800 A4 20 | In distribution | |
| D 800 A2 10 | In distribution | |
| W ML PT A1 20 | In distribution | |
| 5185 LT WH 98-18 | In distribution | |
| D 1300 A1 20 | In distribution | |
| Z 1100 A2 10 | In distribution | |
| Z 1300 A1 18 | In distribution | |
| Z 800 A4 18 | In distribution | |
| Z 1300 A0 12 | In distribution | |
| Z 800 ML 14 | In distribution | |
| D 1100 A4 20 | In distribution | |
| 5181 LT WH 98-10 | In distribution | |
| 5156 HT A2 98-20 | In distribution | |
| Z 800 A3 10 | In distribution | |
| Z 800 A0 18 | In distribution | |
| Z 800 A4 16 | In distribution | |
| D 800 A3 12 | In distribution | |
| W ML PT A3.5 14 | In distribution | |
| Z 1300 A1 14 | In distribution | |
| Z 800 A4 14 | In distribution | |
| D 800 A0 25 | In distribution | |
| Z 800 ML 20 | In distribution | |
| W MO A2 20 | In distribution | |
| Z 1100 A4 25 | In distribution | |
| Z 1300 A1 20 | In distribution | |
| D 1100 A4 25 | In distribution | |
| Z 1300 A0 10 | In distribution | |
| Z 1100 A1 25 | In distribution | |
| Z 1100 ML 10 | In distribution | |
| D 1100 A2 16 | In distribution | |
| Z 800 A3 25 | In distribution | |
| W ML AT A4 10 | In distribution | |
| W ML AT A4 25 | In distribution | |
| 5163 HT WH 98-14 | 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.