Luxen Zr
534 catalogue numbers from LUXEN 1100-30T-D98-MA3, listed by Dentalmax 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
534catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Dentalmax 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) | K171585 |
| Record published | 2019-05-08 |
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 |
|---|---|---|
| LUXEN 1100-30T-D98-MA3 | In distribution | |
| LUXEN 1100-18T-D95-MC2 | In distribution | |
| LUXEN 1100-14T-D95-MC3 | In distribution | |
| LUXEN 1100-14T-D98-MD3 | In distribution | |
| Galaxy Zr 95 E3-22T | In distribution | |
| Galaxy Zr 95 E2-30T | In distribution | |
| LUXEN Zr-14T-D98-E2 | In distribution | |
| LUXEN 1100-20T-D95-MA4 | In distribution | |
| LUXEN 1100-30T-D95-MD3 | In distribution | |
| G44PD_9820_BL3 | In distribution | |
| G44PD_9828_BL2 | In distribution | |
| LUXEN 1100-12T-D95-MC4 | In distribution | |
| LUXEN 1100-12T-D95-MC1 | In distribution | |
| G44PD_9830_BL2 | In distribution | |
| LUXEN Zr-25T-D98-S3 | In distribution | |
| Galaxy Zr 95 E1 -16T | In distribution | |
| LUXEN Zr-12T-D98-HT | In distribution | |
| LUXEN 1100-18T-D95-MA3 | In distribution | |
| LUXEN Zr-16T-D98-E4 | In distribution | |
| LUXEN 1100-14T-D98-MB2 | In distribution | |
| Galaxy Zr 98 E1-14T | In distribution | |
| LUXEN Zr-10T-D95-E2 | In distribution | |
| LUXEN Zr-12T-D98-S3 | In distribution | |
| Galaxy Clear 95 MC3-20T | In distribution | |
| LUXEN 1100-25T-D98-MA3.5 | In distribution | |
| LUXEN Smile-20T-D95-MB4 | In distribution | |
| LUXEN Zr-16T-D95-E3 | In distribution | |
| Galaxy Zr 95 E0 -16T | In distribution | |
| LUXEN Zr-16T-D98-E2 | In distribution | |
| LUXEN Zr-30T-D98-S3 | In distribution | |
| LUXEN Zr-22T-D95-E3 | In distribution | |
| LUXEN 1100-20T-D95-MA3 | In distribution | |
| LUXEN Zr-10T-D98-E1 | In distribution | |
| LUXEN 1100-22T-D95-MB1 | In distribution | |
| LUXEN 1100-22T-D95-MB2 | In distribution | |
| LUXEN 1100-25T-D98-MA2 | In distribution | |
| LUXEN 1100-20T-D95-MC4 | In distribution | |
| Galaxy Zr 98 E1-25T | In distribution | |
| LUXEN 1100-20T-D95-MC3 | In distribution | |
| LUXEN 1100-16T-D95-MC4 | In distribution | |
| LUXEN 1100-20T-D98-MD4 | In distribution | |
| LUXEN 1100-14T-D95-MA2 | In distribution | |
| Galaxy Zr 98 E1-22T | In distribution | |
| LUXEN Zr-16T-D98-E3 | In distribution | |
| LUXEN 1100-16T-D98-MB2 | In distribution | |
| Galaxy Zr 98 E4-22T | In distribution | |
| LUXEN Zr-20T-D95-E4 | In distribution | |
| LUXEN 1100-22T-D98-MC2 | In distribution | |
| Galaxy Zr 95 E0 -12T | In distribution | |
| Galaxy Zr 98 E4-12T | In distribution | |
| LUXEN Zr-16T-D98-S1 | In distribution | |
| Galaxy Zr 98 E0-16T | In distribution | |
| LUXEN 1100-22T-D95-MC1 | In distribution | |
| LUXEN Zr-18T-D98-S1 | In distribution | |
| LUXEN 1100-22T-D98-MA2 | In distribution | |
| Galaxy Zr 95 E3-10T | In distribution | |
| Galaxy Zr 98 A2-20T | In distribution | |
| LUXEN Smile-20T-D95-S1 | In distribution | |
| LUXEN Zr-10T-D98-S3 | In distribution | |
| LUXEN 1100-18T-D95-MD3 | In distribution | |
| LUXEN Zr-25T-D98-E1 | In distribution | |
| LUXEN 1100-18T-D98-MB4 | In distribution | |
| LUXEN Zr-30T-D95-E1 | In distribution | |
| LUXEN 1100-30T-D95-MB2 | In distribution | |
| LUXEN 1100-30T-D98-MB4 | In distribution | |
| LUXEN 1100-16T-D95-MA3 | In distribution | |
| LUXEN 1100-22T-D98-MD2 | In distribution | |
| Galaxy Zr 95 E3-18T | In distribution | |
| Galaxy Clear 95 MC2-20T | In distribution | |
| LUXEN 1100-18T-D98-MA1 | In distribution | |
| LUXEN Zr-30T-D98-HT | In distribution | |
| LUXEN Zr-20T-D95-E2 | In distribution | |
| LUXEN 1100-14T-D95-MC1 | In distribution | |
| LUXEN 1100-30T-D98-MA4 | In distribution | |
| LUXEN Zr-22T-D98-E2 | In distribution | |
| LUXEN 1100-25T-D98-MA3 | In distribution | |
| Galaxy Zr 98 E4-30T | In distribution | |
| LUXEN 1100-12T-D95-MB1 | In distribution | |
| LUXEN 1100-30T-D95-MA4 | In distribution | |
| LUXEN 1100-25T-D95-MB4 | In distribution | |
| LUXEN Smile-20T-D95-MC2 | In distribution | |
| LUXEN 1100-14T-D95-MC4 | In distribution | |
| Galaxy Zr 95 E1 -25T | In distribution | |
| LUXEN 1100-18T-D98-MB3 | In distribution | |
| LUXEN 1100-25T-D95-MA3.5 | In distribution | |
| LUXEN 1100-12T-D95-MD4 | In distribution | |
| Galaxy Zr 98 E1-12T | In distribution | |
| LUXEN Zr-22T-D95-E2 | In distribution | |
| Galaxy Zr 98 E3-16T | In distribution | |
| LUXEN 1100-22T-D98-MD4 | In distribution | |
| LUXEN Zr-18T-D98-S3 | In distribution | |
| LUXEN 1100-30T-D95-MB1 | In distribution | |
| LUXEN 1100-20T-D95-MB3 | In distribution | |
| LUXEN Zr-22T-D95-E0 | In distribution | |
| Galaxy Zr 98 E4-16T | In distribution | |
| LUXEN Zr-16T-D98-E0 | In distribution | |
| LUXEN 1100-16T-D98-MA1 | In distribution | |
| LUXEN 1100-25T-D98-MD3 | In distribution | |
| G44PD_9830_BL1 | In distribution | |
| G44PD_9822_BL1 | In distribution | |
| LUXEN 1100-18T-D95-MB2 | In distribution | |
| LUXEN 1100-12T-D95-MC2 | In distribution | |
| LUXEN Zr-18T-D95-E4 | In distribution | |
| LUXEN 1100-25T-D98-MA1 | In distribution | |
| LUXEN Zr-18T-D98-E4 | In distribution | |
| LUXEN 1100-12T-D98-MA3 | In distribution | |
| LUXEN 1100-20T-D98-MB4 | In distribution | |
| LUXEN 1100-30T-D98-MD4 | In distribution | |
| G44PD_9818_BL1 | In distribution | |
| LUXEN Zr-30T-D98-E0 | In distribution | |
| LUXEN 1100-14T-D98-MA3 | In distribution | |
| G44PD_9818_BL3 | In distribution | |
| LUXEN 1100-18T-D98-MD2 | In distribution | |
| Galaxy Zr 98 A2-30T | In distribution | |
| LUXEN 1100-20T-D98-MA3 | In distribution | |
| LUXEN 1100-25T-D95-MC2 | In distribution | |
| LUXEN 1100-20T-D98-MA3.5 | In distribution | |
| LUXEN Zr-30T-D95-E2 | In distribution | |
| LUXEN Zr-12T-D98-E0 | In distribution | |
| LUXEN 1100-14T-D95-MA3.5 | In distribution | |
| LUXEN 1100-16T-D98-MD2 | In distribution | |
| LUXEN 1100-25T-D95-MB2 | In distribution | |
| Galaxy Zr 95 E1 -14T | In distribution | |
| LUXEN 1100-12T-D95-MA3 | In distribution | |
| LUXEN 1100-12T-D98-MC2 | In distribution | |
| LUXEN 1100-16T-D95-MD4 | In distribution | |
| LUXEN Zr-22T-D98-E1 | In distribution | |
| LUXEN 1100-20T-D98-MC2 | In distribution | |
| LUXEN Smile-20T-D95-MA3 | In distribution | |
| LUXEN Smile-20T-D95-MB3 | In distribution | |
| LUXEN 1100-18T-D98-MC4 | In distribution | |
| LUXEN 1100-30T-D95-MB4 | In distribution | |
| Galaxy Zr 98 E3-25T | In distribution | |
| LUXEN Zr-25T-D98-S2 | In distribution | |
| LUXEN 1100-16T-D98-MB4 | In distribution | |
| LUXEN 1100-18T-D95-MB4 | In distribution | |
| LUXEN 1100-30T-D98-MC2 | In distribution | |
| Galaxy Zr 95 E1 -22T | In distribution | |
| LUXEN 1100-16T-D98-MB1 | In distribution | |
| LUXEN 1100-25T-D95-MC1 | In distribution | |
| LUXEN 1100-12T-D95-MA2 | In distribution | |
| LUXEN 1100-30T-D98-MA3.5 | In distribution | |
| LUXEN 1100-14T-D98-MB3 | In distribution | |
| LUXEN 1100-20T-D98-MC4 | In distribution | |
| LUXEN 1100-18T-D98-MB1 | In distribution | |
| LUXEN 1100-30T-D95-MC1 | In distribution | |
| LUXEN 1100-22T-D98-MC4 | In distribution | |
| LUXEN 1100-14T-D98-MD4 | In distribution | |
| Galaxy Zr 95 E0 -10T | In distribution | |
| LUXEN 1100-22T-D98-MA3.5 | In distribution | |
| Galaxy Clear 95 MA3-20T | In distribution | |
| Galaxy Zr 98 E0-22T | In distribution | |
| LUXEN 1100-30T-D95-MA3 | In distribution | |
| LUXEN 1100-30T-D95-MA3.5 | In distribution | |
| LUXEN Zr-22T-D95-E1 | In distribution | |
| LUXEN 1100-16T-D95-MC3 | In distribution | |
| LUXEN 1100-12T-D98-MB1 | In distribution | |
| G44PD_9818_BL2 | In distribution | |
| LUXEN 1100-18T-D95-MA3.5 | In distribution | |
| LUXEN 1100-25T-D98-MB1 | In distribution | |
| LUXEN Zr-14T-D98-S2 | In distribution | |
| Galaxy Zr 95 E0 -30T | In distribution | |
| LUXEN Smile-20T-D95-MA4 | In distribution | |
| LUXEN Zr-12T-D98-E2 | In distribution | |
| LUXEN 1100-16T-D98-MA3 | In distribution | |
| LUXEN Zr-10T-D98-HT | In distribution | |
| Galaxy Zr 98 E0-10T | In distribution | |
| LUXEN Zr-22T-D95-E4 | In distribution | |
| LUXEN 1100-16T-D95-MB3 | In distribution | |
| LUXEN Zr-12T-D95-E2 | In distribution | |
| LUXEN Smile-20T-D95-HT | In distribution | |
| LUXEN 1100-12T-D95-MB3 | In distribution | |
| LUXEN 1100-25T-D98-MC3 | In distribution | |
| Galaxy Zr 98 E2-12T | In distribution | |
| LUXEN 1100-20T-D98-MB1 | In distribution | |
| LUXEN 1100-22T-D98-MB4 | In distribution | |
| Galaxy Zr 98 E4-10T | In distribution | |
| LUXEN 1100-20T-D95-MC1 | In distribution | |
| LUXEN Zr-30T-D98-E4 | In distribution | |
| LUXEN 1100-30T-D95-MA1 | In distribution | |
| LUXEN 1100-14T-D95-MB1 | In distribution | |
| Galaxy Zr 98 A2-22T | In distribution | |
| LUXEN 1100-14T-D98-MA1 | In distribution | |
| LUXEN Zr-14T-D98-E3 | In distribution | |
| LUXEN 1100-12T-D95-MD3 | In distribution | |
| LUXEN 1100-16T-D95-MB2 | In distribution | |
| LUXEN Zr-18T-D95-E3 | In distribution | |
| LUXEN 1100-12T-D98-MA2 | In distribution | |
| LUXEN Zr-30T-D95-E4 | In distribution | |
| Galaxy Zr 98 E2-18T | In distribution | |
| Galaxy Zr 95 E2-18T | In distribution | |
| Galaxy Zr 98 E3-22T | In distribution | |
| Galaxy Zr 95 E2-16T | In distribution | |
| Galaxy Zr 95 E3-25T | In distribution | |
| LUXEN Zr-22T-D98-E3 | In distribution | |
| LUXEN Zr-16T-D95-E2 | In distribution | |
| LUXEN 1100-18T-D98-MC2 | In distribution | |
| LUXEN 1100-18T-D95-MA4 | In distribution | |
| LUXEN Zr-12T-D95-E3 | In distribution | |
| LUXEN 1100-16T-D95-MD3 | In distribution | |
| LUXEN 1100-25T-D98-MB4 | In distribution | |
| LUXEN 1100-30T-D98-MC3 | In distribution | |
| LUXEN 1100-18T-D98-MB2 | In distribution | |
| LUXEN Zr-16T-D95-E0 | In distribution | |
| LUXEN Zr-20T-D98-E4 | In distribution | |
| LUXEN 1100-22T-D95-MD4 | In distribution | |
| LUXEN Zr-30T-D95-E0 | In distribution | |
| LUXEN Zr-30T-D98-E2 | In distribution | |
| Galaxy Zr 98 E1-30T | In distribution | |
| LUXEN 1100-12T-D98-MB4 | In distribution | |
| Galaxy Zr 95 E0 -20T | In distribution | |
| LUXEN Smile -20T-D95-MHT | In distribution | |
| Galaxy Zr 98 E0-14T | In distribution | |
| LUXEN Zr-12T-D95-E4 | In distribution | |
| LUXEN Smile-20T-D95-MB2 | In distribution | |
| LUXEN 1100-16T-D95-MC2 | In distribution | |
| LUXEN 1100-16T-D98-MD3 | In distribution | |
| Galaxy Zr 98 E0-12T | In distribution | |
| Galaxy Zr 98 A2-18T | In distribution | |
| LUXEN 1100-22T-D95-MC2 | In distribution | |
| LUXEN 1100-25T-D95-MC3 | In distribution | |
| Galaxy Zr 98 A2-10T | In distribution | |
| Galaxy Zr 98 E0-18T | In distribution | |
| LUXEN 1100-20T-D95-MA3.5 | In distribution | |
| Galaxy Zr 98 E3-18T | In distribution | |
| G44PD_9814_BL2 | In distribution | |
| LUXEN Zr-25T-D98-E2 | In distribution | |
| Galaxy Zr 98 E3-30T | In distribution | |
| LUXEN Zr-10T-D95-E0 | In distribution | |
| Galaxy Zr 98 E4-18T | In distribution | |
| LUXEN Smile-20T-D95-MD2 | In distribution | |
| LUXEN 1100-20T-D98-MC3 | In distribution | |
| LUXEN 1100-25T-D95-MB1 | In distribution | |
| Galaxy Zr 95 E2-22T | In distribution | |
| LUXEN Zr-10T-D98-S1 | In distribution | |
| LUXEN 1100-30T-D95-MC4 | In distribution | |
| LUXEN Zr-25T-D98-E4 | In distribution | |
| LUXEN 1100-22T-D95-MA2 | In distribution | |
| G44PD_9814_BL3 | In distribution | |
| LUXEN 1100-14T-D95-MD2 | In distribution | |
| LUXEN Zr-18T-D95-E1 | In distribution | |
| LUXEN 1100-14T-D95-MB2 | In distribution | |
| Galaxy Zr 98 E3-20T | In distribution | |
| LUXEN 1100-14T-D95-MD4 | In distribution | |
| LUXEN 1100-22T-D98-MB3 | In distribution | |
| LUXEN 1100-14T-D95-MA4 | In distribution | |
| LUXEN 1100-14T-D95-MB3 | In distribution | |
| G44PD_9828_BL3 | In distribution | |
| Galaxy Zr 98 E1-16T | In distribution | |
| LUXEN Zr-25T-D95-E2 | 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 |
|---|---|
| K241151 | 2024-09-30 |
| K212548 | 2021-12-06 |
| K171585 | 2018-10-31 |
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.