Luxen 5g
3,903 catalogue numbers from Luxen ML D95 C1 16T, 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
3,903catalogue 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) | K241151 |
| Record published | 2025-01-14 |
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 |
|---|---|---|---|
| Luxen ML D95 C1 16T | In distribution | ||
| Luxen Smile GL D98 B1 12T | In distribution | ||
| Luxen ML D95 MBL2 14T | In distribution | ||
| Luxen Smile ML D95 C1 20T | In distribution | ||
| Luxen Smile ML D95 A3 20T | In distribution | ||
| Luxen Enamel D95 B3 16T | In distribution | ||
| Luxen Enamel G D95 D2 25T | In distribution | ||
| Luxen Smile GL D95 C2 20T | In distribution | ||
| Luxen Smile P D95 A2 18T | In distribution | ||
| Luxen Smile GL D98 C2 28T | In distribution | ||
| Luxen Smile D98 C1 18T | In distribution | ||
| Luxen Smile ML D95 C4 22T | In distribution | ||
| Luxen Enamel G D95 D3 16T | In distribution | ||
| Luxen Smile G D95 C2 22T | In distribution | ||
| Luxen Smile GL D95 D4 16T | In distribution | ||
| Luxen ML D95 C2 18T | In distribution | ||
| Luxen Smile ML D95 MBLW 22T | In distribution | ||
| Luxen Smile D95 A2 25T | In distribution | ||
| Luxen Enamel GB D98 B4 12T | In distribution | ||
| Luxen Smile ML D98 B4 12T | In distribution | ||
| Luxen Smile D98 C1 12T | In distribution | ||
| Luxen Zr D95 C2 14T | In distribution | ||
| Luxen Smile D98 SMS1 12T | In distribution | ||
| Luxen Smile P D98 C2 18T | In distribution | ||
| Luxen Smile D98 A3 20T | In distribution | ||
| Luxen Smile D95 SMS3 18T | In distribution | ||
| Luxen Enamel D95 D3 14T | In distribution | ||
| Luxen Enamel D95 E1 20T | In distribution | ||
| Luxen ML D95 A2 28T | In distribution | ||
| Luxen Zr D95 A4 22T | In distribution | ||
| Luxen ML D98 MBL3 25T | In distribution | ||
| Luxen Smile GL D98 A3.5 16T | In distribution | ||
| Luxen Smile D98 A3.5 20T | In distribution | ||
| Luxen Smile GL D98 C2 16T | In distribution | ||
| Luxen Enamel D95 B4 10T | In distribution | ||
| Luxen Smile ML D98 A4 30T | In distribution | ||
| Luxen Smile ML D98 D2 28T | In distribution | ||
| Luxen ML D98 MBL1 25T | In distribution | ||
| Luxen Enamel GB D98 B2 30T | In distribution | ||
| Luxen Zr D98 A1 28T | In distribution | ||
| Luxen Enamel G D95 A2 14T | In distribution | ||
| Luxen Smile GL D95 B2 10T | In distribution | ||
| Luxen Enamel D98 HT 12T | In distribution | ||
| Luxen Enamel GB D98 B2 28T | In distribution | ||
| Luxen Enamel D95 D2 14T | In distribution | ||
| Luxen Smile P D98 D2 25T | In distribution | ||
| Luxen Enamel G D98 D2 18T | In distribution | ||
| Luxen Enamel D98 A3 20T | In distribution | ||
| Luxen Smile G D98 A1 20T | In distribution | ||
| Luxen Enamel GB D95 D4 16T | In distribution | ||
| Luxen ML D95 B4 14T | In distribution | ||
| Luxen Smile ML D95 B3 18T | In distribution | ||
| Luxen Smile GL D95 C3 20T | In distribution | ||
| Luxen Enamel G D98 A4 22T | In distribution | ||
| Luxen Smile ML D95 B3 16T | In distribution | ||
| Luxen Enamel GB D98 A1 18T | In distribution | ||
| Luxen Enamel GB D95 A3 30T | In distribution | ||
| Luxen ML D98 Dark 30T | In distribution | ||
| Luxen Enamel GB D95 B4 14T | In distribution | ||
| Luxen Enamel G D98 A1 18T | In distribution | ||
| Luxen ML D98 C1 30T | In distribution | ||
| Luxen Smile ML D95 A3.5 30T | In distribution | ||
| Luxen Smile G D98 A3 20T | In distribution | ||
| Luxen Smile GL D98 C4 12T | In distribution | ||
| Luxen Smile P D98 B4 25T | In distribution | ||
| Luxen ML D95 Light 14T | In distribution | ||
| Luxen Smile D95 C4 10T | In distribution | ||
| Luxen Smile D95 C3 20T | In distribution | ||
| Luxen Smile P D95 A4 25T | In distribution | ||
| Luxen Smile ML D98 A1 10T | In distribution | ||
| Luxen Smile P D98 A3 16T | In distribution | ||
| Luxen Zr D98 C1 22T | In distribution | ||
| Luxen Smile GL D95 B4 10T | In distribution | ||
| Luxen Smile GL D95 SBL2 30T | In distribution | ||
| Luxen Enamel GB D95 B3 16T | In distribution | ||
| Luxen Enamel D98 E3 25T | In distribution | ||
| Luxen Enamel D98 A1 28T | In distribution | ||
| Luxen ML D98 B3 14T | In distribution | ||
| Luxen Smile D98 SMS2 28T | In distribution | ||
| Luxen Zr D98 B1 10T | In distribution | ||
| Luxen Smile D98 SMS1 16T | In distribution | ||
| Luxen Zr D98 C4 18T | In distribution | ||
| Luxen Smile ML D95 B4 30T | In distribution | ||
| Luxen Enamel G D98 C1 12T | In distribution | ||
| Luxen ML D98 A3.5 28T | In distribution | ||
| Luxen Smile G D95 B2 20T | In distribution | ||
| Luxen Smile G D95 D4 18T | In distribution | ||
| Luxen Smile P D95 A2 30T | In distribution | ||
| Luxen Enamel G D98 D2 14T | In distribution | ||
| Luxen ML D95 Dark 10T | In distribution | ||
| Luxen ML D98 A2 14T | In distribution | ||
| Luxen Smile ML D98 B4 16T | In distribution | ||
| Luxen Smile D95 HT 12T | In distribution | ||
| Luxen Smile GL D95 A3 28T | In distribution | ||
| Luxen Enamel D98 E1 30T | In distribution | ||
| Luxen Smile ML D95 D2 20T | In distribution | ||
| Luxen Smile GL D98 C3 28T | In distribution | ||
| Luxen Smile ML D98 B2 22T | In distribution | ||
| Luxen Smile P D95 A3 14T | In distribution | ||
| Luxen Smile GL D98 B3 22T | In distribution | ||
| Luxen Smile ML D98 A4 28T | In distribution | ||
| Luxen Enamel G D95 C2 18T | In distribution | ||
| Luxen Enamel G D98 B3 20T | In distribution | ||
| Luxen Smile P D95 A2 28T | In distribution | ||
| Luxen Smile G D95 D2 12T | In distribution | ||
| Luxen Enamel G D98 B1 10T | In distribution | ||
| Luxen ML D98 C4 16T | In distribution | ||
| Luxen Zr D95 B2 30T | In distribution | ||
| Luxen Enamel D95 E3 14T | In distribution | ||
| Luxen Enamel G D95 B2 12T | In distribution | ||
| Luxen Smile GL D98 C2 18T | In distribution | ||
| Luxen Enamel G D98 B3 30T | In distribution | ||
| Luxen ML D95 A1 25T | In distribution | ||
| Luxen Smile GL D95 SBL3 30T | In distribution | ||
| Luxen Enamel GB D98 D2 16T | In distribution | ||
| Luxen Smile P D98 C3 12T | In distribution | ||
| Luxen Smile D95 HT 20T | In distribution | ||
| Luxen Zr D95 C3 22T | In distribution | ||
| Luxen Smile D98 SMS3 22T | In distribution | ||
| Luxen Smile ML D98 MBL2 28T | In distribution | ||
| Luxen Enamel GB D95 B4 20T | In distribution | ||
| Luxen Smile G D95 C4 20T | In distribution | ||
| Luxen Enamel D98 E1 20T | In distribution | ||
| Luxen Smile ML D98 C1 12T | In distribution | ||
| Luxen Enamel G D95 B1 10T | In distribution | ||
| Luxen Smile ML D98 A4 20T | In distribution | ||
| Luxen Enamel GB D98 A4 16T | In distribution | ||
| Luxen Smile GL D95 SBL3 28T | In distribution | ||
| Luxen Zr D98 C1 18T | In distribution | ||
| Luxen Smile D98 B4 28T | In distribution | ||
| Luxen Smile ML D98 D2 14T | In distribution | ||
| Luxen Zr D95 C3 20T | In distribution | ||
| Luxen Smile GL D95 D2 14T | In distribution | ||
| Luxen Smile D98 SMS3 30T | In distribution | ||
| Luxen Enamel D98 B4 25T | In distribution | ||
| Luxen ML D95 A1 18T | In distribution | ||
| Luxen Enamel G D95 D2 14T | In distribution | ||
| Luxen Enamel D95 B2 12T | In distribution | ||
| Luxen Smile GL D95 A3.5 30T | In distribution | ||
| Luxen Smile GL D95 SBL3 14T | In distribution | ||
| Luxen Zr D95 C1 22T | In distribution | ||
| Luxen Enamel B65 E2 | 4 | In distribution | |
| Luxen Smile GL D95 B2 25T | In distribution | ||
| Luxen Enamel D98 HT 28T | In distribution | ||
| Luxen Smile D98 SMS3 28T | In distribution | ||
| Luxen Enamel D98 A3 30T | In distribution | ||
| Luxen Smile D98 C4 10T | In distribution | ||
| Luxen Zr D98 B2 22T | In distribution | ||
| Luxen Zr D98 D3 28T | In distribution | ||
| Luxen ML D98 Medium 25T | In distribution | ||
| Luxen Smile GL D98 D2 22T | In distribution | ||
| Luxen ML D98 D3 25T | In distribution | ||
| Luxen Smile ML D98 A4 10T | In distribution | ||
| Luxen Smile D95 C2 25T | In distribution | ||
| Luxen Smile P D95 C4 30T | In distribution | ||
| Luxen Smile ML D98 C4 28T | In distribution | ||
| Luxen Zr D95 A1 18T | In distribution | ||
| Luxen Zr D95 C1 16T | In distribution | ||
| Luxen Zr D98 B2 18T | In distribution | ||
| Luxen Smile P D95 B4 22T | In distribution | ||
| Luxen Enamel GB D95 A4 28T | In distribution | ||
| Luxen Smile GL D95 D4 30T | In distribution | ||
| Luxen ML D95 B4 25T | In distribution | ||
| Luxen Smile GL D98 A3 14T | In distribution | ||
| Luxen Zr D95 B4 14T | In distribution | ||
| Luxen ML D95 A1 14T | In distribution | ||
| Luxen Smile ML D98 MBLW 14T | In distribution | ||
| Luxen ML D95 A1 12T | In distribution | ||
| Luxen ML D98 C1 20T | In distribution | ||
| Luxen Smile P D98 A3 22T | In distribution | ||
| Luxen Zr D98 A4 18T | In distribution | ||
| Luxen Smile GL D95 A3.5 20T | In distribution | ||
| Luxen Smile GL D95 C4 18T | In distribution | ||
| Luxen Enamel D95 B1 12T | In distribution | ||
| Luxen Smile GL D95 A3 30T | In distribution | ||
| Luxen Smile GL D95 C3 28T | In distribution | ||
| Luxen ML D98 D3 14T | In distribution | ||
| Luxen Smile P D98 A2 16T | In distribution | ||
| Luxen Enamel G D98 A4 28T | In distribution | ||
| Luxen Enamel G D98 C2 25T | In distribution | ||
| Luxen Smile ML D98 B4 22T | In distribution | ||
| Luxen Smile D95 B1 30T | In distribution | ||
| Luxen Enamel GB D98 C4 16T | In distribution | ||
| Luxen Zr D98 S3 28T | In distribution | ||
| Luxen Enamel G D95 D2 20T | In distribution | ||
| Luxen Smile G D95 A4 30T | In distribution | ||
| Luxen Zr D95 B4 10T | In distribution | ||
| Luxen ML D98 MBL3 12T | In distribution | ||
| Luxen Smile GL D98 A3 10T | In distribution | ||
| Luxen Enamel G D95 B4 14T | In distribution | ||
| Luxen Smile G D95 C2 18T | In distribution | ||
| Luxen Smile GL D95 C1 14T | In distribution | ||
| Luxen Smile D95 A1 18T | In distribution | ||
| Luxen Smile ML D95 MBL2 25T | In distribution | ||
| Luxen ML D95 Dark 30T | In distribution | ||
| Luxen Smile P D95 B1 10T | In distribution | ||
| Luxen Enamel D98 D3 25T | In distribution | ||
| Luxen Smile P D98 A3 18T | In distribution | ||
| Luxen Enamel 4019 E0 | 4 | In distribution | |
| Luxen Smile G D98 D2 10T | In distribution | ||
| Luxen Smile G D95 C3 16T | In distribution | ||
| Luxen Smile D95 A1 12T | In distribution | ||
| Luxen Smile P D98 A1 12T | In distribution | ||
| Luxen Smile G D98 B3 10T | In distribution | ||
| Luxen Enamel GB D98 A3 14T | In distribution | ||
| Luxen Smile GL D95 A3.5 18T | In distribution | ||
| Luxen Smile ML D95 A3 14T | In distribution | ||
| Luxen Smile G D98 D4 20T | In distribution | ||
| Luxen Enamel D98 D3 30T | In distribution | ||
| Luxen Enamel GB D95 C4 20T | In distribution | ||
| Luxen Smile ML D95 A2 16T | In distribution | ||
| Luxen Enamel D98 C3 25T | In distribution | ||
| Luxen Enamel G D95 BL1 14T | In distribution | ||
| Luxen Smile G D95 C3 18T | In distribution | ||
| Luxen Enamel G D98 A3.5 16T | In distribution | ||
| Luxen Smile G D98 A4 20T | In distribution | ||
| Luxen Zr D95 A4 16T | In distribution | ||
| Luxen Enamel D98 B2 30T | In distribution | ||
| Luxen ML D95 A4 14T | In distribution | ||
| Luxen Smile GL D95 A4 22T | In distribution | ||
| Luxen Smile ML D95 C4 16T | In distribution | ||
| Luxen Enamel G D98 B2 22T | In distribution | ||
| Luxen Enamel G D98 C4 20T | In distribution | ||
| Luxen Enamel GB D98 D3 16T | In distribution | ||
| Luxen Enamel D95 HT 30T | In distribution | ||
| Luxen Enamel G D95 D3 25T | In distribution | ||
| Luxen Enamel D95 C3 20T | In distribution | ||
| Luxen Enamel G D95 B4 16T | In distribution | ||
| Luxen Enamel D98 B1 22T | In distribution | ||
| Luxen Enamel D98 D3 20T | In distribution | ||
| Luxen Smile ML D95 A1 25T | In distribution | ||
| Luxen Enamel G D98 A2 10T | In distribution | ||
| Luxen Enamel G D98 BL1 30T | In distribution | ||
| Luxen Smile P D95 A1 18T | In distribution | ||
| Luxen Smile G D98 C3 10T | In distribution | ||
| Luxen Smile D95 SMS2 25T | In distribution | ||
| Luxen Zr D98 C1 14T | In distribution | ||
| Luxen Smile ML D95 B3 25T | In distribution | ||
| Luxen Enamel G D98 A3 10T | In distribution | ||
| Luxen Smile ML D95 B4 28T | In distribution | ||
| Luxen ML D98 B4 22T | In distribution | ||
| Luxen Zr D98 C3 14T | In distribution | ||
| Luxen Smile D95 D2 28T | In distribution | ||
| Luxen Zr D95 B4 30T | In distribution | ||
| Luxen ML D98 Dark 18T | In distribution | ||
| Luxen Smile P D98 C4 18T | In distribution | ||
| Luxen Enamel GB D95 A3.5 20T | In distribution | ||
| Luxen Smile P D95 C3 30T | In distribution | ||
| Luxen Zr D95 B3 22T | In distribution | ||
| Luxen Enamel D98 C1 16T | 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 |
| 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 |
| IPS e.max CAD | Ivoclar Vivadent Aktiengesellschaft | 1,045 |
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.