Mazic Claro CAD
Glass Ceramic for CAD System; B32, Impulse Opal 1 Mandrel type*3ea
33manufacturers in China registered for this device type
188catalogue 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 | Vericom Co., Ltd., South Korea |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2025-05-21 |
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 | Per pack | Status |
|---|---|---|---|
| MCC14-0BL4 | 5 | In distribution | |
| MCC40-0MO1 | 2 | In distribution | |
| MCC40-LTD3 | 2 | In distribution | |
| MCC40-LBL4 | 2 | In distribution | |
| MCC40-HTD2 | 2 | In distribution | |
| MCC40-LTA4 | 2 | In distribution | |
| MCC12-LMO4 | 5 | In distribution | |
| MCC14-LMO4 | 5 | In distribution | |
| MCC12-LMO3 | 5 | In distribution | |
| MCC12-LBL4 | 5 | In distribution | |
| MCC14-LTC1 | 5 | In distribution | |
| MCC12-LTD3 | 5 | In distribution | |
| MCC32-LBL3 | 3 | In distribution | |
| MCC32-LTD3 | 3 | In distribution | |
| MCC14-0BL3 | 5 | In distribution | |
| MCC32-HTA1 | 3 | In distribution | |
| MCC12-LTC2 | 5 | In distribution | |
| MCC12-HTB2 | 5 | In distribution | |
| MCC40-HTA2 | 2 | In distribution | |
| MCC14-HTA4 | 5 | In distribution | |
| MCC32-0MO0 | 3 | In distribution | |
| MCC14-HTA3 | 5 | In distribution | |
| MCC14-HTB3 | 5 | In distribution | |
| MCC40-HTC1 | 2 | In distribution | |
| MCC14-LTD2 | 5 | In distribution | |
| MCC14-LTB2 | 5 | In distribution | |
| MCC14-LBL1 | 5 | In distribution | |
| MCC12-LBL1 | 5 | In distribution | |
| MCC40-0BL4 | 2 | In distribution | |
| MCC32-HTD2 | 3 | In distribution | |
| MCC32-HTC1 | 3 | In distribution | |
| MCC12-HTB3 | 5 | In distribution | |
| MCC40-0MO2 | 2 | In distribution | |
| MCC14-0BL1 | 5 | In distribution | |
| MCC14-HTB4 | 5 | In distribution | |
| MCC32-HTA5 | 3 | In distribution | |
| MCC32-LMO3 | 3 | In distribution | |
| MCC14-HTD4 | 5 | In distribution | |
| MCC32-HTA2 | 3 | In distribution | |
| MCC40-LTB2 | 2 | In distribution | |
| MCC12-HTC3 | 5 | In distribution | |
| MCC14-LTA4 | 5 | In distribution | |
| MCC12-0MO1 | 5 | In distribution | |
| MCC12-HTA5 | 5 | In distribution | |
| MCC14-HTA2 | 5 | In distribution | |
| MCC14-LMO3 | 5 | In distribution | |
| MCC14-HTC1 | 5 | In distribution | |
| MCC12-HTD3 | 5 | In distribution | |
| MCC12-LTB2 | 5 | In distribution | |
| MCC12-HTA2 | 5 | In distribution | |
| MCC12-HTC1 | 5 | In distribution | |
| MCC32-LTA4 | 3 | In distribution | |
| MCC40-HTC4 | 2 | In distribution | |
| MCC14-LTC2 | 5 | In distribution | |
| MCC14-HTB2 | 5 | In distribution | |
| MCC40-LTA1 | 2 | In distribution | |
| MCC32-HTC4 | 3 | In distribution | |
| MCC40-HTB3 | 2 | In distribution | |
| MCC12-LTA4 | 5 | In distribution | |
| MCC32-LTB4 | 3 | In distribution | |
| MCC40-LBL1 | 2 | In distribution | |
| MCC14-LTC4 | 5 | In distribution | |
| MCC32-LMO4 | 3 | In distribution | |
| MCC40-HTB1 | 2 | In distribution | |
| MCC32-LTB3 | 3 | In distribution | |
| MCC12-LBL3 | 5 | In distribution | |
| MCC14-LTD4 | 5 | In distribution | |
| MCC40-LTD2 | 2 | In distribution | |
| MCC32-LTA5 | 3 | In distribution | |
| MCC40-HTA1 | 2 | In distribution | |
| MCC12-0BL4 | 5 | In distribution | |
| MCC32-HTD3 | 3 | In distribution | |
| MCC40-LTA2 | 2 | In distribution | |
| MCC14-LTA3 | 5 | In distribution | |
| MCC40-LTC3 | 2 | In distribution | |
| MCC32-HTB3 | 3 | In distribution | |
| MCC32-LTD2 | 3 | In distribution | |
| MCC14-LTA5 | 5 | In distribution | |
| MCC12-HTD2 | 5 | In distribution | |
| MCC32-LOP1 | 3 | In distribution | |
| MCC32-0BL1 | 3 | In distribution | |
| MCC32-HTB1 | 3 | In distribution | |
| MCC40-HTA5 | 2 | In distribution | |
| MCC40-HTC2 | 2 | In distribution | |
| MCC40-0BL3 | 2 | In distribution | |
| MCC32-LTB1 | 3 | In distribution | |
| MCC32-LTD4 | 3 | In distribution | |
| MCC32-LTA2 | 3 | In distribution | |
| MCC32-HTD4 | 3 | In distribution | |
| MCC40-LTC1 | 2 | In distribution | |
| MCC40-LTB3 | 2 | In distribution | |
| MCC14-HTC2 | 5 | In distribution | |
| MCC14-LOP1 | 5 | In distribution | |
| MCC12-LOP2 | 5 | In distribution | |
| MCC14-LOP2 | 5 | In distribution | |
| MCC14-HTB1 | 5 | In distribution | |
| MCC12-HTC4 | 5 | In distribution | |
| MCC40-0MO0 | 2 | In distribution | |
| MCC40-0BL2 | 2 | In distribution | |
| MCC14-LTC3 | 5 | In distribution | |
| MCC12-LOP1 | 5 | In distribution | |
| MCC14-0BL2 | 5 | In distribution | |
| MCC40-LTA5 | 2 | In distribution | |
| MCC40-LTA3 | 2 | In distribution | |
| MCC40-LTB4 | 2 | In distribution | |
| MCC14-0MO0 | 5 | In distribution | |
| MCC40-HTC3 | 2 | In distribution | |
| MCC12-LTC4 | 5 | In distribution | |
| MCC32-LTC3 | 3 | In distribution | |
| MCC40-LTC2 | 2 | In distribution | |
| MCC40-LMO3 | 2 | In distribution | |
| MCC14-HTD3 | 5 | In distribution | |
| MCC32-LBL2 | 3 | In distribution | |
| MCC40-LTB1 | 2 | In distribution | |
| MCC12-HTC2 | 5 | In distribution | |
| MCC32-LTC4 | 3 | In distribution | |
| MCC14-LTB1 | 5 | In distribution | |
| MCC14-LTA1 | 5 | In distribution | |
| MCC14-LBL4 | 5 | In distribution | |
| MCC12-LBL2 | 5 | In distribution | |
| MCC14-HTC4 | 5 | In distribution | |
| MCC14-HTA1 | 5 | In distribution | |
| MCC14-LBL3 | 5 | In distribution | |
| MCC12-0BL2 | 5 | In distribution | |
| MCC32-LTC1 | 3 | In distribution | |
| MCC40-LBL3 | 2 | In distribution | |
| MCC12-LTA2 | 5 | In distribution | |
| MCC12-LTB1 | 5 | In distribution | |
| MCC12-LTC3 | 5 | In distribution | |
| MCC32-HTA3 | 3 | In distribution | |
| MCC12-LTD2 | 5 | In distribution | |
| MCC32-HTC2 | 3 | In distribution | |
| MCC32-HTA4 | 3 | In distribution | |
| MCC14-LTB4 | 5 | In distribution | |
| MCC32-0MO2 | 3 | In distribution | |
| MCC32-0BL3 | 3 | In distribution | |
| MCC32-HTB4 | 3 | In distribution | |
| MCC14-LTB3 | 5 | In distribution | |
| MCC32-LTA1 | 3 | In distribution | |
| MCC32-LBL4 | 3 | In distribution | |
| MCC40-HTB2 | 2 | In distribution | |
| MCC40-LOP2 | 2 | In distribution | |
| MCC14-HTA5 | 5 | In distribution | |
| MCC32-0MO1 | 3 | In distribution | |
| MCC12-0BL1 | 5 | In distribution | |
| MCC32-0BL2 | 3 | In distribution | |
| MCC40-HTD3 | 2 | In distribution | |
| MCC40-HTA4 | 2 | In distribution | |
| MCC12-LTD4 | 5 | In distribution | |
| MCC32-LTA3 | 3 | In distribution | |
| MCC12-HTD4 | 5 | In distribution | |
| MCC32-HTC3 | 3 | In distribution | |
| MCC32-LBL1 | 3 | In distribution | |
| MCC32-0BL4 | 3 | In distribution | |
| MCC12-HTA4 | 5 | In distribution | |
| MCC40-0BL1 | 2 | In distribution | |
| MCC40-LTC4 | 2 | In distribution | |
| MCC14-LTD3 | 5 | In distribution | |
| MCC12-HTA1 | 5 | In distribution | |
| MCC14-HTD2 | 5 | In distribution | |
| MCC40-HTD4 | 2 | In distribution | |
| MCC12-HTA3 | 5 | In distribution | |
| MCC14-LBL2 | 5 | In distribution | |
| MCC12-LTC1 | 5 | In distribution | |
| MCC12-HTB1 | 5 | In distribution | |
| MCC12-HTB4 | 5 | In distribution | |
| MCC40-HTA3 | 2 | In distribution | |
| MCC40-HTB4 | 2 | In distribution | |
| MCC12-0MO2 | 5 | In distribution | |
| MCC12-0BL3 | 5 | In distribution | |
| MCC14-LTA2 | 5 | In distribution | |
| MCC32-LOP2 | 3 | In distribution | |
| MCC12-LTB4 | 5 | In distribution | |
| MCC32-HTB2 | 3 | In distribution | |
| MCC40-LMO4 | 2 | In distribution | |
| MCC14-0MO2 | 5 | In distribution | |
| MCC32-LTC2 | 3 | In distribution | |
| MCC14-0MO1 | 5 | In distribution | |
| MCC12-LTA5 | 5 | In distribution | |
| MCC40-LBL2 | 2 | In distribution | |
| MCC12-LTA1 | 5 | In distribution | |
| MCC12-LTB3 | 5 | In distribution | |
| MCC32-LTB2 | 3 | In distribution | |
| MCC40-LTD4 | 2 | In distribution | |
| MCC14-HTC3 | 5 | In distribution | |
| MCC40-LOP1 | 2 | In distribution | |
| MCC12-LTA3 | 5 | In distribution | |
| MCC12-0MO0 | 5 | 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 |
|---|---|
| K203672 | 2021-07-01 |
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.