Luxen Smile, Luxen Zr
779 catalogue numbers from Multi D95 A3 25T, 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
779catalogue 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 | 2022-02-06 |
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 |
|---|---|---|
| Multi D95 A3 25T | In distribution | |
| ML 1200 600 Multi P D95 HT 18T | In distribution | |
| Multi D98 D3 14T | In distribution | |
| En D95 HT 10T | In distribution | |
| En D95 A3 16T | In distribution | |
| ML 1200 600 Multi P D95 C1 30T | In distribution | |
| Multi D98 A3 30T | In distribution | |
| ML 1200 600 Multi P D95 C2 18T | In distribution | |
| En D95 A3 22T | In distribution | |
| ML 1200 600 Multi P D95 B4 18T | In distribution | |
| ML 1200 600 Multi P D95 C3 22T | In distribution | |
| ML 600 D98 A3 20T | In distribution | |
| ML 1200 600 Multi P D95 C1 18T | In distribution | |
| Multi D98 B2 16T | In distribution | |
| ML 600 D95 A3 18T | In distribution | |
| En D98 A4 18T | In distribution | |
| ML 1200 600 Multi P D95 B3 25T | In distribution | |
| Multi D98 D2 20T | In distribution | |
| ML 1200 600 Multi P D98 D4 30T | In distribution | |
| Multi D98 A3 22T | In distribution | |
| Multi D98 B1 30T | In distribution | |
| Multi D95 C4 14T | In distribution | |
| En D98 HT 12T | In distribution | |
| ML 1200 600 Multi P D95 MHT Light 16T | In distribution | |
| ML 1200 600 Multi P D98 B1 30T | In distribution | |
| ML 600 D95 A3 12T | In distribution | |
| Multi D95 D3 14T | In distribution | |
| ML 600 D98 A3 16T | In distribution | |
| Multi D98 C3 30T | In distribution | |
| ML 1200 600 Multi P D98 D4 18T | In distribution | |
| ML 600 D95 A1 16T | In distribution | |
| ML 1200 600 Multi P D98 D4 14T | In distribution | |
| Multi D95 A4 30T | In distribution | |
| ML 1200 600 Multi P D95 D4 16T | In distribution | |
| ML 1200 600 Multi P D98 B4 25T | In distribution | |
| ML 1200 600 Multi P D95 B2 20T | In distribution | |
| Multi D98 B4 14T | In distribution | |
| ML 1200 600 Multi P D98 A1 12T | In distribution | |
| En D98 HT 20T | In distribution | |
| En D98 HT 18T | In distribution | |
| ML 1200 600 Multi P D95 MHT Dark 22T | In distribution | |
| ML 1200 600 Multi P D95 C3 16T | In distribution | |
| ML 1200 600 Multi P D98 A2 12T | In distribution | |
| ML 1200 600 Multi P D95 HT 14T | In distribution | |
| En D95 A1 18T | In distribution | |
| En D95 A1 16T | In distribution | |
| Multi D95 C1 20T | In distribution | |
| ML 1200 600 Multi P D98 B4 16T | In distribution | |
| Multi D95 D3 16T | In distribution | |
| En D95 A4 10T | In distribution | |
| Multi D98 A3 12T | In distribution | |
| En D95 A3 18T | In distribution | |
| ML 1200 600 Multi P D95 D2 20T | In distribution | |
| ML 600 D95 A1 25T | In distribution | |
| Multi D95 A1 16T | In distribution | |
| ML 1200 600 Multi P D98 MHT Light 22T | In distribution | |
| Multi D95 D4 12T | In distribution | |
| En D95 HT 20T | In distribution | |
| En D98 A3 16T | In distribution | |
| ML 600 D98 HT 30T | In distribution | |
| ML 1200 600 Multi P D98 C3 25T | In distribution | |
| En D98 A3 18T | In distribution | |
| Multi D98 D2 12T | In distribution | |
| ML 1200 600 Multi P D95 MHT Dark 18T | In distribution | |
| Multi D95 D2 25T | In distribution | |
| ML 1200 600 Multi P D95 A1 25T | In distribution | |
| En D95 A2 25T | In distribution | |
| En D95 A4 30T | In distribution | |
| ML 1200 600 Multi P D95 B2 14T | In distribution | |
| Multi D98 B1 22T | In distribution | |
| En D98 A3 10T | In distribution | |
| ML 1200 600 Multi P D98 MHT Dark 20T | In distribution | |
| Multi D95 A2 18T | In distribution | |
| Multi D95 A1 20T | In distribution | |
| Multi D95 A3.5 22T | In distribution | |
| Multi D98 D4 12T | In distribution | |
| ML 1200 600 Multi P D95 B3 18T | In distribution | |
| En D98 A4 12T | In distribution | |
| Multi D95 C3 18T | In distribution | |
| Multi D95 A3.5 16T | In distribution | |
| ML 1200 600 Multi P D98 D4 16T | In distribution | |
| Zr-16T-D98-S1 | In distribution | |
| Multi D98 D3 18T | In distribution | |
| En D98 A3 14T | In distribution | |
| ML 1200 600 Multi P D95 MHT Light 22T | In distribution | |
| Multi D98 A3.5 30T | In distribution | |
| En D95 A2 12T | In distribution | |
| ML 1200 600 Multi P D95 B3 30T | In distribution | |
| Multi D95 D2 20T | In distribution | |
| Zr-16T-D98-S2 | In distribution | |
| ML 1200 600 Multi P D95 C3 20T | In distribution | |
| En D95 A2 18T | In distribution | |
| ML 1200 600 Multi P D95 C3 30T | In distribution | |
| ML 1200 600 Multi P D98 A2 18T | In distribution | |
| Multi D95 C2 30T | In distribution | |
| En D98 A3 12T | In distribution | |
| ML 1200 600 Multi P D95 C4 12T | In distribution | |
| Multi D98 C1 20T | In distribution | |
| En D98 A1 10T | In distribution | |
| ML 600 D98 HT 10T | In distribution | |
| Multi D98 D4 30T | In distribution | |
| En D95 A1 12T | In distribution | |
| ML 600 D95 A3 20T | In distribution | |
| ML 1200 600 Multi P D98 C1 14T | In distribution | |
| En D95 A4 25T | In distribution | |
| ML 1200 600 Multi P D98 A4 16T | In distribution | |
| ML 1200 600 Multi P D98 C4 12T | In distribution | |
| ML 1200 600 Multi P D98 HT 25T | In distribution | |
| Multi D98 B3 16T | In distribution | |
| Multi D98 C2 14T | In distribution | |
| ML 1200 600 Multi P D95 C3 18T | In distribution | |
| ML 1200 600 Multi P D98 MHT Medium 18T | In distribution | |
| ML 600 D98 HT 25T | In distribution | |
| ML 1200 600 Multi P D98 C4 18T | In distribution | |
| Multi D98 D2 16T | In distribution | |
| ML 600 D98 HT 12T | In distribution | |
| Multi D98 A4 20T | In distribution | |
| Multi D95 A3 16T | In distribution | |
| Multi D95 B4 14T | In distribution | |
| Multi D95 A1 12T | In distribution | |
| ML 1200 600 Multi P D95 A3.5 25T | In distribution | |
| ML 600 D98 A2 22T | In distribution | |
| En D98 A4 22T | In distribution | |
| Multi D98 C4 22T | In distribution | |
| Multi D95 C1 16T | In distribution | |
| ML 1200 600 Multi P D98 A4 18T | In distribution | |
| ML 1200 600 Multi P D98 MHT Dark 22T | In distribution | |
| Multi D95 A3 12T | In distribution | |
| En D98 A4 25T | In distribution | |
| ML 600 D95 A2 16T | In distribution | |
| En D95 A4 18T | In distribution | |
| ML 1200 600 Multi P D95 B1 30T | In distribution | |
| ML 1200 600 Multi P D98 B1 14T | In distribution | |
| ML 1200 600 Multi P D95 HT 16T | In distribution | |
| Multi D98 B4 20T | In distribution | |
| ML 1200 600 Multi P D95 A4 18T | In distribution | |
| Multi D95 A2 12T | In distribution | |
| ML 1200 600 Multi P D98 MHT Medium 14T | In distribution | |
| Multi D95 A3.5 18T | In distribution | |
| ML 1200 600 Multi P D95 B2 30T | In distribution | |
| ML 1200 600 Multi P D95 MHT Medium 25T | In distribution | |
| ML 1200 600 Multi P D98 A3.5 20T | In distribution | |
| ML 1200 600 Multi P D95 B3 14T | In distribution | |
| Multi D98 D2 30T | In distribution | |
| ML 1200 600 Multi P D98 C2 30T | In distribution | |
| ML 1200 600 Multi P D98 B4 18T | In distribution | |
| ML 1200 600 Multi P D98 A4 30T | In distribution | |
| Zr-30T-D98-S2 | In distribution | |
| Multi D95 B3 22T | In distribution | |
| Zr-12T-D98-S1 | In distribution | |
| ML 1200 600 Multi P D95 A3 12T | In distribution | |
| ML 1200 600 Multi P D95 MHT Medium 14T | In distribution | |
| ML 1200 600 Multi P D98 A4 12T | In distribution | |
| ML 1200 600 Multi P D95 C1 22T | In distribution | |
| Multi D95 A3.5 12T | In distribution | |
| ML 1200 600 Multi P D98 B1 20T | In distribution | |
| ML 600 D98 A1 10T | In distribution | |
| En D98 A1 12T | In distribution | |
| ML 1200 600 Multi P D95 A3.5 22T | In distribution | |
| Multi D95 B3 25T | In distribution | |
| ML 1200 600 Multi P D95 B3 12T | In distribution | |
| ML 1200 600 Multi P D98 C4 25T | In distribution | |
| ML 1200 600 Multi P D98 D2 16T | In distribution | |
| ML 1200 600 Multi P D95 B2 16T | In distribution | |
| ML 1200 600 Multi P D95 B2 12T | In distribution | |
| ML 600 D98 A3 22T | In distribution | |
| Multi D95 C3 22T | In distribution | |
| Zr-12T-D98-S3 | In distribution | |
| ML 600 D95 HT 10T | In distribution | |
| Multi D98 D3 30T | In distribution | |
| Multi D98 A3.5 18T | In distribution | |
| Multi D95 D2 16T | In distribution | |
| ML 1200 600 Multi P D95 HT 20T | In distribution | |
| Multi D98 A3.5 12T | In distribution | |
| Multi D98 C1 22T | In distribution | |
| ML 600 D95 A2 12T | In distribution | |
| ML 1200 600 Multi P D95 A1 12T | In distribution | |
| ML 1200 600 Multi P D98 D2 20T | In distribution | |
| Multi D95 D4 22T | In distribution | |
| Multi D98 D3 12T | In distribution | |
| ML 1200 600 Multi P D98 C2 12T | In distribution | |
| Multi D98 A3 14T | In distribution | |
| Multi D98 B3 14T | In distribution | |
| Multi D98 C3 16T | In distribution | |
| ML 1200 600 Multi P D95 B4 30T | In distribution | |
| ML 1200 600 Multi P D95 C3 25T | In distribution | |
| ML 1200 600 Multi P D98 D3 14T | In distribution | |
| En D98 A1 16T | In distribution | |
| ML 1200 600 Multi P D98 MHT Light 20T | In distribution | |
| ML 1200 600 Multi P D98 D2 30T | In distribution | |
| ML 1200 600 Multi P D98 C1 30T | In distribution | |
| En D95 A1 14T | In distribution | |
| ML 1200 600 Multi P D98 A3 25T | In distribution | |
| Multi D95 C4 30T | In distribution | |
| Multi D95 C3 20T | In distribution | |
| ML 1200 600 Multi P D98 C2 25T | In distribution | |
| Multi D95 A4 22T | In distribution | |
| En D98 HT 14T | In distribution | |
| ML 600 D95 HT 25T | In distribution | |
| Multi D95 C1 25T | In distribution | |
| ML 1200 600 Multi P D98 HT 12T | In distribution | |
| ML 1200 600 Multi P D95 A2 20T | In distribution | |
| ML 1200 600 Multi P D95 D4 20T | In distribution | |
| En D98 A2 20T | In distribution | |
| Multi D98 C4 14T | In distribution | |
| Multi D98 A1 16T | In distribution | |
| Multi D98 C1 14T | In distribution | |
| ML 1200 600 Multi P D95 D3 14T | In distribution | |
| Multi D95 B2 30T | In distribution | |
| ML 1200 600 Multi P D98 D4 20T | In distribution | |
| En D98 A2 10T | In distribution | |
| Multi D95 B2 14T | In distribution | |
| En D95 A4 16T | In distribution | |
| ML 1200 600 Multi P D98 A2 30T | In distribution | |
| Multi D98 A1 14T | In distribution | |
| En D95 A3 20T | In distribution | |
| Multi D98 B4 25T | In distribution | |
| Multi D95 C4 18T | In distribution | |
| ML 1200 600 Multi P D98 C4 22T | In distribution | |
| ML 1200 600 Multi P D98 C4 20T | In distribution | |
| ML 600 D95 HT 12T | In distribution | |
| En D98 A1 30T | In distribution | |
| ML 1200 600 Multi P D95 MHT Light 18T | In distribution | |
| ML 1200 600 Multi P D98 B4 22T | In distribution | |
| En D95 HT 14T | In distribution | |
| Multi D95 D4 16T | In distribution | |
| ML 1200 600 Multi P D98 MHT Medium 20T | In distribution | |
| ML 1200 600 Multi P D98 C2 16T | In distribution | |
| ML 1200 600 Multi P D98 C1 12T | In distribution | |
| ML 1200 600 Multi P D98 B3 14T | In distribution | |
| Multi D98 A4 14T | In distribution | |
| ML 1200 600 Multi P D95 MHT Dark 16T | In distribution | |
| ML 600 D98 HT 22T | In distribution | |
| Multi D95 B3 16T | In distribution | |
| Multi D95 D2 14T | In distribution | |
| ML 1200 600 Multi P D95 A3 30T | In distribution | |
| ML 1200 600 Multi P D98 B4 14T | In distribution | |
| ML 1200 600 Multi P D98 A3.5 25T | In distribution | |
| ML 1200 600 Multi P D95 C2 14T | In distribution | |
| ML 1200 600 Multi P D95 D4 12T | In distribution | |
| ML 1200 600 Multi P D95 A3 25T | In distribution | |
| ML 1200 600 Multi P D98 A2 25T | In distribution | |
| ML 1200 600 Multi P D95 A1 30T | In distribution | |
| Multi D98 A4 22T | In distribution | |
| ML 1200 600 Multi P D98 B3 18T | In distribution | |
| Multi D98 A1 12T | In distribution | |
| ML 1200 600 Multi P D95 B1 18T | In distribution | |
| ML 1200 600 Multi P D98 MHT Dark 16T | In distribution | |
| ML 1200 600 Multi P D98 B2 16T | In distribution | |
| Multi D98 B1 25T | 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.