Luxen Smile
778 catalogue numbers from Galaxy Clear 95 MC1-30T, 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
778catalogue 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 | 2019-04-15 |
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 |
|---|---|---|
| Galaxy Clear 95 MC1-30T | In distribution | |
| Galaxy Clear 95 MB2-30T | In distribution | |
| Luxen Smile SE-10T-D98-A2 | In distribution | |
| LUXEN Smile-22T-D98-MB4 | In distribution | |
| Luxen Smile SE Mulit-25T-D98-A3.5 | In distribution | |
| LUXEN Smile-22T-D95-MA4 | In distribution | |
| Galaxy Clear 98 MA3.5-30T | In distribution | |
| Luxen Smile SE Mulit-22T-D98-D2 | In distribution | |
| Galaxy Clear 95 MA3-12T | In distribution | |
| LUXEN Smile-22T-D95-S2 | In distribution | |
| LUXEN Smile-22T-D95-S1 | In distribution | |
| LUXEN Smile-14T-D95-S3 | In distribution | |
| LUXEN Smile-18T-D95-S1 | In distribution | |
| Galaxy Clear 98 MA3.5-14T | In distribution | |
| LUXEN Smile-16T-D98-MC3 | In distribution | |
| Galaxy Clear 98 MD3-25T | In distribution | |
| Luxen Smile SE Mulit-22T-D98-B3 | In distribution | |
| LUXEN Smile-20T-D98-S2 | In distribution | |
| LUXEN Smile-16T-D98-MA2 | In distribution | |
| Galaxy Clear 98 MC1-20T | In distribution | |
| M45PD_9812_BL3 | In distribution | |
| LUXEN Smile-18T-D98-MD4 | In distribution | |
| Galaxy Clear 98 MD2-20T | In distribution | |
| LUXEN Smile-18T-D95-S3 | In distribution | |
| LUXEN Smile-18T-D95-S1 | In distribution | |
| Galaxy Clear 95 MA2-12T | In distribution | |
| Luxen Smile SE Mulit-12T-D98-A1 | In distribution | |
| Galaxy Clear 95 MD2-30T | In distribution | |
| LUXEN Smile-16T-D95-MB4 | In distribution | |
| Luxen Smile SE-22T-D98-S1 | In distribution | |
| Luxen Smile SE-14T-D98-A0 | In distribution | |
| LUXEN Smile-12T-D95-S3 | In distribution | |
| Galaxy Clear 98 MD3-22T | In distribution | |
| LUXEN Smile-10T-D95-S3 | In distribution | |
| Galaxy Clear 98 MC1-16T | In distribution | |
| Luxen Smile SE-22T-D98-A1 | In distribution | |
| LUXEN Smile-22T-D98-S1 | In distribution | |
| LUXEN Smile-20T-D98-S3 | In distribution | |
| LUXEN Smile-16T-D95-MD4 | In distribution | |
| LUXEN Smile-25T-D95-MA2 | In distribution | |
| Luxen Smile SE Mulit-25T-D98-A2 | In distribution | |
| Galaxy Clear 95 MD2-12T | In distribution | |
| LUXEN Smile-25T-D98-MB1 | In distribution | |
| LUXEN Smile-16T-D98-MA4 | In distribution | |
| Galaxy Clear 95 MA1-30T | In distribution | |
| Galaxy Clear 98 MD3-18T | In distribution | |
| Luxen Smile SE Mulit-16T-D98-B3 | In distribution | |
| Luxen Smile SE-16T-D98-S2 | In distribution | |
| LUXEN Smile -30T-D98-MHT | In distribution | |
| LUXEN Smile-12T-D95-MC3 | In distribution | |
| LUXEN Smile-25T-D95-MB4 | In distribution | |
| LUXEN Smile-14T-D98-MD3 | In distribution | |
| LUXEN Smile-25T-D95-MC2 | In distribution | |
| Galaxy Clear 95 MA3.5-14T | In distribution | |
| Luxen Smile SE Mulit-30T-D98-B2 | In distribution | |
| Galaxy Clear 95 MB1-14T | In distribution | |
| Galaxy Clear 95 MB1-12T | In distribution | |
| LUXEN Smile-12T-D98-MC4 | In distribution | |
| LUXEN Smile-16T-D95-MC1 | In distribution | |
| Galaxy Clear 95 MC3-12T | In distribution | |
| LUXEN Smile-16T-D98-HT | In distribution | |
| LUXEN Smile-30T-D98-MA4 | In distribution | |
| Galaxy Clear 98 MD3-14T | In distribution | |
| LUXEN Smile-20T-D98-MC2 | In distribution | |
| LUXEN Smile-25T-D95-MC3 | In distribution | |
| LUXEN Smile-12T-D98-MB1 | In distribution | |
| Galaxy Clear 98 MA1-14T | In distribution | |
| Luxen Smile SE-14T-D98-S2 | In distribution | |
| Galaxy Clear 98 MA3.5-22T | In distribution | |
| Luxen Smile SE Mulit-25T-D98-D3 | In distribution | |
| Galaxy Clear 95 MA3-22T | In distribution | |
| LUXEN Smile-30T-D95-MB2 | In distribution | |
| Galaxy Clear 95 MB1-22T | In distribution | |
| LUXEN Smile-14T-D95-MC4 | In distribution | |
| Galaxy Clear 98 MD2-16T | In distribution | |
| Luxen Smile SE Mulit-25T-D98-A3 | In distribution | |
| Luxen Smile SE Mulit-14T-D98-A3.5 | In distribution | |
| Galaxy Clear 95 MB3-22T | In distribution | |
| LUXEN Smile-14T-D98-MA2 | In distribution | |
| LUXEN Smile-30T-D98-S3 | In distribution | |
| LUXEN Smile-22T-D98-MB2 | In distribution | |
| LUXEN Smile-25T-D95-MA3 | In distribution | |
| LUXEN Smile -12T-D98-MHT | In distribution | |
| Luxen Smile SE-20T-D98-A2 | In distribution | |
| Galaxy Clear 95 MA3.5-30T | In distribution | |
| Galaxy Clear 98 MA3-16T | In distribution | |
| LUXEN Smile-22T-D98-S2 | In distribution | |
| Galaxy Clear 98 MA3-18T | In distribution | |
| Luxen Smile SE Mulit-14T-D98-C2 | In distribution | |
| Luxen Smile SE Mulit-12T-D98-B4 | In distribution | |
| Galaxy Clear 95 MA1-25T | In distribution | |
| Luxen Smile SE-22T-D98-A2 | In distribution | |
| Galaxy Clear 95 MA3.5-18T | In distribution | |
| Galaxy Clear 95 MB1-16T | In distribution | |
| M45PD_9814_BL3 | In distribution | |
| LUXEN Smile-12T-D95-MB2 | In distribution | |
| Galaxy Clear 95 MC1-12T | In distribution | |
| Luxen Smile SE-20T-D98-S3 | In distribution | |
| LUXEN Smile-22T-D95-S1 | In distribution | |
| Luxen Smile SE Mulit-18T-D98-B3 | In distribution | |
| LUXEN Smile -25T-D95-MHT | In distribution | |
| LUXEN Smile -14T-D98-MHT | In distribution | |
| Galaxy Clear 95 MB2-25T | In distribution | |
| Luxen Smile SE Mulit-25T-D98-A1 | In distribution | |
| Luxen Smile SE Mulit-22T-D98-A1 | In distribution | |
| Luxen Smile SE Mulit-14T-D98-D4 | In distribution | |
| Luxen Smile SE-20T-D98-S1 | In distribution | |
| M45PD_9830_BL2 | In distribution | |
| Galaxy Clear 98 MB1-22T | In distribution | |
| LUXEN Smile-16T-D98-MB2 | In distribution | |
| Luxen Smile SE-14T-D98-A1 | In distribution | |
| LUXEN Smile -22T-D98-MHT | In distribution | |
| LUXEN Smile-25T-D95-HT | In distribution | |
| Luxen Smile SE-25T-D98-A0 | In distribution | |
| Galaxy Clear 95 MC2-25T | In distribution | |
| Galaxy Clear 98 MC3-12T | In distribution | |
| Luxen Smile SE Mulit-22T-D98-B2 | In distribution | |
| Luxen Smile SE Mulit-18T-D98-D4 | In distribution | |
| LUXEN Smile-16T-D98-S2 | In distribution | |
| Luxen Smile SE-25T-D98-A1 | In distribution | |
| M45PD_9830_BL3 | In distribution | |
| Luxen Smile SE Mulit-12T-D98-D4 | In distribution | |
| Luxen Smile SE Mulit-25T-D98-B3 | In distribution | |
| LUXEN Smile-30T-D98-MB3 | In distribution | |
| LUXEN Smile-16T-D95-S1 | In distribution | |
| Luxen Smile SE Mulit-18T-D98-D2 | In distribution | |
| Galaxy Clear 98 -25T | In distribution | |
| Luxen Smile SE-16T-D98-A3 | In distribution | |
| Galaxy Clear 98 MA1-12T | In distribution | |
| Luxen Smile SE-12T-D98-S2 | In distribution | |
| LUXEN Smile-14T-D95-MA3 | In distribution | |
| Luxen Smile SE-16T-D98-S3 | In distribution | |
| LUXEN Smile-10T-D95-S2 | In distribution | |
| LUXEN Smile-20T-D98-MA3.5 | In distribution | |
| LUXEN Smile-18T-D98-S2 | In distribution | |
| Luxen Smile SE Mulit-16T-D98-D2 | In distribution | |
| LUXEN Smile-18T-D98-MA3.5 | In distribution | |
| LUXEN Smile-18T-D98-S1 | In distribution | |
| Galaxy Clear 98 MA2-14T | In distribution | |
| LUXEN Smile-25T-D95-MD2 | In distribution | |
| Galaxy Clear 95 MC3-22T | In distribution | |
| Galaxy Clear 95 MA2-30T | In distribution | |
| Galaxy Clear 95 MD3-18T | In distribution | |
| Galaxy Clear 98 MA2-20T | In distribution | |
| Galaxy Clear 95 MA1-22T | In distribution | |
| Luxen Smile SE Mulit-18T-D98-C4 | In distribution | |
| LUXEN Smile-25T-D95-MB2 | In distribution | |
| Galaxy Clear 98 MA3-20T | In distribution | |
| M45PD_9816_BL1 | In distribution | |
| LUXEN Smile-30T-D98-MA3.5 | In distribution | |
| Luxen Smile SE Mulit-14T-D98-B1 | In distribution | |
| LUXEN Smile-25T-D95-S1 | In distribution | |
| LUXEN Smile-14T-D95-S3 | In distribution | |
| Luxen Smile SE Mulit-30T-D98-D2 | In distribution | |
| Galaxy Clear 95 MB3-16T | In distribution | |
| Luxen Smile SE Mulit-12T-D98-A3 | In distribution | |
| LUXEN Smile-30T-D95-S1 | In distribution | |
| Galaxy Clear 95 MD2-25T | In distribution | |
| LUXEN Smile-30T-D95-HT | In distribution | |
| Galaxy Clear 95 MC2-22T | In distribution | |
| M45PD_9828_BL1 | In distribution | |
| Luxen Smile SE Mulit-16T-D98-A1 | In distribution | |
| Luxen Smile SE Mulit-18T-D98-B2 | In distribution | |
| Luxen Smile SE-18T-D98-S1 | In distribution | |
| Galaxy Clear 98 MB1-30T | In distribution | |
| Luxen Smile SE Mulit-22T-D98-C4 | In distribution | |
| LUXEN Smile-20T-D98-MA1 | In distribution | |
| LUXEN Smile-22T-D95-MC2 | In distribution | |
| LUXEN Smile-18T-D98-MA4 | In distribution | |
| Galaxy Clear 98 MB3-22T | In distribution | |
| Luxen Smile SE-16T-D98-S1 | In distribution | |
| Galaxy Clear 95 MD3-12T | In distribution | |
| LUXEN Smile-12T-D98-MD2 | In distribution | |
| LUXEN Smile-22T-D95-MD3 | In distribution | |
| LUXEN Smile-16T-D95-MA3 | In distribution | |
| LUXEN Smile-12T-D95-HT | In distribution | |
| LUXEN Smile-10T-D95-S2 | In distribution | |
| LUXEN Smile-22T-D95-MB3 | In distribution | |
| Luxen Smile SE Mulit-14T-D98-C1 | In distribution | |
| LUXEN Smile-18T-D95-MC4 | In distribution | |
| Galaxy Clear 95 MC2-14T | In distribution | |
| LUXEN Smile-16T-D98-MA1 | In distribution | |
| LUXEN Smile-22T-D95-S2 | In distribution | |
| Galaxy Clear 95 MA3-25T | In distribution | |
| Luxen Smile SE-25T-D98-HT | In distribution | |
| Galaxy Clear 95 MD2-14T | In distribution | |
| LUXEN Smile-18T-D98-MD2 | In distribution | |
| Galaxy Clear 98 MB2-30T | In distribution | |
| LUXEN Smile-18T-D95-S3 | In distribution | |
| Luxen Smile SE Mulit-30T-D98-C1 | In distribution | |
| Galaxy Clear 98 -16T | In distribution | |
| LUXEN Smile-25T-D98-MA1 | In distribution | |
| LUXEN Smile-14T-D98-HT | In distribution | |
| Luxen Smile SE Mulit-16T-D98-C2 | In distribution | |
| M45PD_9828_BL2 | In distribution | |
| LUXEN Smile-30T-D95-S2 | In distribution | |
| LUXEN Smile-18T-D95-MA3.5 | In distribution | |
| LUXEN Smile-30T-D95-S3 | In distribution | |
| Galaxy Clear 95 MA3.5-25T | In distribution | |
| Galaxy Clear 95 MC3-18T | In distribution | |
| Galaxy Clear 98 MC2-25T | In distribution | |
| Luxen Smile SE Mulit-22T-D98-A4 | In distribution | |
| Galaxy Clear 95 MA1-16T | In distribution | |
| LUXEN Smile-14T-D95-MB4 | In distribution | |
| LUXEN Smile-25T-D98-MD3 | In distribution | |
| Galaxy Clear 98 MC3-30T | In distribution | |
| Luxen Smile SE Mulit-22T-D98-A2 | In distribution | |
| LUXEN Smile-12T-D98-MA4 | In distribution | |
| LUXEN Smile-14T-D98-MD4 | In distribution | |
| M45PD_9820_BL3 | In distribution | |
| Galaxy Clear 95 MD3-30T | In distribution | |
| LUXEN Smile -16T-D95-MHT | In distribution | |
| LUXEN Smile-14T-D95-MA1 | In distribution | |
| Luxen Smile SE Mulit-14T-D98-B4 | In distribution | |
| Luxen Smile SE-14T-D98-S3 | In distribution | |
| Galaxy Clear 98 MC3-22T | In distribution | |
| LUXEN Smile -18T-D95-MHT | In distribution | |
| Galaxy Clear 95 MC1-14T | In distribution | |
| LUXEN Smile-25T-D95-MB1 | In distribution | |
| LUXEN Smile-20T-D98-MC3 | In distribution | |
| Galaxy Clear 95 MD3-16T | In distribution | |
| Galaxy Clear 95 MC3-25T | In distribution | |
| Luxen Smile SE Mulit-25T-D98-C1 | In distribution | |
| LUXEN Smile-25T-D98-MC4 | In distribution | |
| LUXEN Smile-20T-D98-MB3 | In distribution | |
| LUXEN Smile-18T-D95-MB4 | In distribution | |
| LUXEN Smile-30T-D98-MA2 | In distribution | |
| Luxen Smile SE Mulit-30T-D98-A4 | In distribution | |
| LUXEN Smile-14T-D98-MA4 | In distribution | |
| Luxen Smile SE Mulit-22T-D98-A3 | In distribution | |
| Galaxy Clear 98 MC2-18T | In distribution | |
| LUXEN Smile-12T-D95-MD4 | In distribution | |
| Luxen Smile SE Mulit-18T-D98-B4 | In distribution | |
| Galaxy Clear 95 MB2-16T | In distribution | |
| LUXEN Smile-30T-D95-MA2 | In distribution | |
| Galaxy Clear 98 MC2-20T | In distribution | |
| LUXEN Smile-18T-D98-S3 | In distribution | |
| Luxen Smile SE Mulit-14T-D98-C3 | In distribution | |
| LUXEN Smile-18T-D95-MA3 | In distribution | |
| Luxen Smile SE Mulit-20T-D98-A3 | In distribution | |
| LUXEN Smile-22T-D98-MD4 | In distribution | |
| Galaxy Clear 95 MD2-22T | In distribution | |
| Galaxy Clear 95 MA3-16T | In distribution | |
| LUXEN Smile-12T-D95-MB4 | In distribution | |
| Luxen Smile SE-22T-D98-HT | In distribution | |
| Luxen Smile SE Mulit-16T-D98-D4 | In distribution | |
| Luxen Smile SE-16T-D98-HT | In distribution | |
| Luxen Smile SE-20T-D98-HT | In distribution | |
| Luxen Smile SE-18T-D98-S2 | In distribution | |
| LUXEN Smile-16T-D95-S2 | 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.