Luxisse+
YTTRIA STABILIZED ZIRCONIA, 1100 MPa BEND STRENGTH, 41% LIGHT TRANSMITTANCE
33manufacturers in China registered for this device type
599catalogue numbers in this listing
2510(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 | Heany Industries, Inc., United States |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| 510(k) | K150056 |
| Record published | 2019-11-05 |
| Record revised | 2018-07-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Outer diameter 17 to 100 mm; width 10 to 42 mm; height 10 to 42 mm; length 63.5 to 110 mm; outer diameter 0.639 in; height 1.231 in; weight 20 mg; depth 18 mm |
| Distribution end date | 2022-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D | Width 16 mm | In distribution |
| D | Width 25 mm | In distribution |
| 0 | Outer Diameter 98 mm | In distribution |
| 0 | Width 17 mm | In distribution |
| D | Width 20 mm | In distribution |
| D | Width 14 mm | In distribution |
| 0 | Outer Diameter 17 mm | In distribution |
| D | In distribution | |
| D | Width 12 mm | In distribution |
| A | Height 14 mm | In distribution |
| D | Width 25 mm | In distribution |
| D | Width 14 mm | In distribution |
| D | Width 12 mm | In distribution |
| 0 | In distribution | |
| 0 | Height 12 mm | In distribution |
| D | Width 20 mm | In distribution |
| G | Width 16 mm | In distribution |
| D | Width 20 mm | In distribution |
| D | Width 22 mm | In distribution |
| 0 | Outer Diameter 100 mm | In distribution |
| G | In distribution | |
| A | Outer Diameter 94 mm | In distribution |
| 0 | Outer Diameter 98 mm | In distribution |
| A | Height 18 mm | In distribution |
| 0 | Width 17 mm | In distribution |
| D | Outer Diameter 17 mm | In distribution |
| A | Height 14 mm | In distribution |
| 0 | Height 14 mm | In distribution |
| 0 | Outer Diameter 100 mm | In distribution |
| D | Width 20 mm | In distribution |
| D | Width 20 mm | In distribution |
| D | Width 12 mm | In distribution |
| D | Width 20 mm | In distribution |
| D | Width 16 mm | In distribution |
| D | Width 25 mm | In distribution |
| 0 | Height 10.2 mm | In distribution |
| 0 | Height 25 mm | In distribution |
| 0 | Height 20 mm | In distribution |
| D | Width 20 mm | In distribution |
| 0 | Outer Diameter 17 mm | In distribution |
| 0 | Outer Diameter 100 mm | In distribution |
| D | Length 110 mm | In distribution |
| D | Width 25 mm | In distribution |
| 0 | Width 10.2 mm | In distribution |
| 0 | Width 42 mm | In distribution |
| D | Width 14 mm | In distribution |
| D | Width 12 mm | In distribution |
| G | Height 30 mm | In distribution |
| 0 | Height 10.2 mm | In distribution |
| D | Width 18 mm | In distribution |
| D | Width 25 mm | In distribution |
| D | Width 22 mm | In distribution |
| D | Width 14 mm | In distribution |
| 0 | Width 17 mm | In distribution |
| D | Width 14 mm | In distribution |
| 0 | Outer Diameter 95 mm | In distribution |
| D | Width 12 mm | In distribution |
| 0 | Height 14 mm | In distribution |
| D | Width 16 mm | In distribution |
| 0 | In distribution | |
| D | Width 16 mm | In distribution |
| D | Width 22 mm | In distribution |
| D | Width 18 mm | In distribution |
| B | Width 18 mm | In distribution |
| A | Outer Diameter 95 mm | In distribution |
| A | Height 18 mm | In distribution |
| D | Width 16 mm | In distribution |
| D | Width 20 mm | In distribution |
| 0 | Width 42 mm | In distribution |
| 0 | Height 18 mm | In distribution |
| D | Outer Diameter 100 mm | In distribution |
| D | Width 18 mm | In distribution |
| D | In distribution | |
| A | In distribution | |
| 0 | Width 38.4 mm | In distribution |
| 0 | Height 12 mm | In distribution |
| D | Width 20 mm | In distribution |
| D | Width 22 mm | In distribution |
| D | Width 25 mm | In distribution |
| D | Width 20 mm | In distribution |
| D | Width 18 mm | In distribution |
| B | Outer Diameter 95 mm | In distribution |
| A | Height 14 mm | In distribution |
| A | Height 14 mm | In distribution |
| D | Width 14 mm | In distribution |
| A | Width 14 mm | In distribution |
| D | Outer Diameter 100 mm | In distribution |
| G | In distribution | |
| 0 | Height 25 mm | In distribution |
| D | Width 22 mm | In distribution |
| D | Width 14 mm | In distribution |
| A | Outer Diameter 98 mm | In distribution |
| D | In distribution | |
| 0 | Height 18 mm | In distribution |
| 0 | Outer Diameter 94 mm | In distribution |
| D | Width 16 mm | In distribution |
| D | Width 18 mm | In distribution |
| D | Width 22 mm | In distribution |
| D | Length 110 mm | In distribution |
| D | Weight 20 mg | In distribution |
| D | Width 12 mm | In distribution |
| B | Outer Diameter.639 in | In distribution |
| B | Outer Diameter 98 mm | In distribution |
| D | In distribution | |
| D | Outer Diameter 17 mm | In distribution |
| A | Height 25 mm | In distribution |
| 0 | In distribution | |
| D | Width 22 mm | In distribution |
| A | Width 20 mm | In distribution |
| A | Width 22 mm | In distribution |
| A | In distribution | |
| 0 | Width 42 mm | In distribution |
| 0 | Width 10 mm | In distribution |
| D | In distribution | |
| 0 | Outer Diameter 94 mm | In distribution |
| A | Height 20 mm | In distribution |
| 0 | Height 16 mm | In distribution |
| A | In distribution | |
| D | Width 14 mm | In distribution |
| D | Outer Diameter 94 mm | In distribution |
| D | Width 22 mm | In distribution |
| A | Outer Diameter 98 mm | In distribution |
| D | Width 18 mm | In distribution |
| A | Outer Diameter 98 mm | In distribution |
| 0 | Width 42 mm | In distribution |
| D | In distribution | |
| 0 | Height 20 mm | In distribution |
| A | Width 14 mm | In distribution |
| B | Outer Diameter.639 in | In distribution |
| A | Width 12 mm | In distribution |
| A | Width 16 mm | In distribution |
| D | Outer Diameter 100 mm | In distribution |
| D | Width 12 mm | In distribution |
| 0 | Width 17 mm | In distribution |
| D | Width 18 mm | In distribution |
| 0 | Outer Diameter 95 mm | In distribution |
| A | Height 12 mm | In distribution |
| D | Width 25 mm | In distribution |
| 0 | Outer Diameter 17 mm | In distribution |
| 0 | Outer Diameter 17 mm | In distribution |
| D | Width 22 mm | In distribution |
| D | Width 16 mm | In distribution |
| D | Width 22 mm | In distribution |
| 0 | Height 18 mm | In distribution |
| D | Width 20 mm | In distribution |
| A | Outer Diameter 95 mm | In distribution |
| D | Width 20 mm | In distribution |
| 0 | Height 12 mm | In distribution |
| D | In distribution | |
| A | Width 16 mm | In distribution |
| 0 | Width 17 mm | In distribution |
| D | Width 22 mm | In distribution |
| 0 | Height 12 mm | In distribution |
| A | Height 12 mm | In distribution |
| D | Width 20 mm | In distribution |
| D | Width 20 mm | In distribution |
| A | Outer Diameter 98 mm | In distribution |
| D | Width 25 mm | In distribution |
| D | Width 22 mm | In distribution |
| A | Width 16 mm | In distribution |
| D | Length 110 mm | In distribution |
| 0 | Outer Diameter 17 mm | In distribution |
| D | Width 16 mm | In distribution |
| 0 | Outer Diameter 17 mm | In distribution |
| D | In distribution | |
| D | Width 20 mm | In distribution |
| D | Outer Diameter 100 mm | In distribution |
| 0 | Width 42 mm | In distribution |
| A | Outer Diameter 98 mm | In distribution |
| D | Width 22 mm | In distribution |
| D | Width 16 mm | In distribution |
| C | Length 110 mm | In distribution |
| D | Width 16 mm | In distribution |
| 0 | Outer Diameter 17 mm | In distribution |
| D | Outer Diameter 17 mm | In distribution |
| D | Outer Diameter 17 mm | In distribution |
| 0 | Outer Diameter 100 mm | In distribution |
| D | Width 25 mm | In distribution |
| G | Height 16 mm | In distribution |
| 0 | Height 16 mm | In distribution |
| D | Width 20 mm | In distribution |
| D | Width 16 mm | In distribution |
| D | Width 25 mm | In distribution |
| D | Width 14 mm | In distribution |
| D | Width 20 mm | In distribution |
| A | Height 14 mm | In distribution |
| 0 | Height 16 mm | In distribution |
| B | Width 14 mm | In distribution |
| A | Height 16 mm | In distribution |
| D | In distribution | |
| A | Width 14 mm | In distribution |
| 0 | Height 18 mm | In distribution |
| D | Width 20 mm | In distribution |
| A | Width 14 mm | In distribution |
| D | Width 16 mm | In distribution |
| D | Width 16 mm | In distribution |
| A | Height 16 mm | In distribution |
| D | Width 16 mm | In distribution |
| D | Width 14 mm | In distribution |
| G | Width 16 mm | In distribution |
| B | Width 22 mm | In distribution |
| D | Outer Diameter 94 mm | In distribution |
| 0 | Height 10.2 mm | In distribution |
| 0 | Outer Diameter 98 mm | In distribution |
| D | Width 18 mm | In distribution |
| D | In distribution | |
| D | Width 12 mm | In distribution |
| D | Width 16 mm | In distribution |
| 0 | Height 25 mm | In distribution |
| D | Width 22 mm | In distribution |
| G | Height 25 mm | In distribution |
| D | Width 12 mm | In distribution |
| D | Width 12 mm | In distribution |
| D | In distribution | |
| D | Width 22 mm | In distribution |
| 0 | Outer Diameter 100 mm | In distribution |
| D | Width 16 mm | In distribution |
| D | Width 20 mm | In distribution |
| D | Width 18 mm | In distribution |
| A | Outer Diameter 98 mm | In distribution |
| D | Width 14 mm | In distribution |
| D | Width 22 mm | In distribution |
| 0 | Height 18 mm | In distribution |
| D | Width 20 mm | In distribution |
| A | Height 16 mm | In distribution |
| D | Width 16 mm | In distribution |
| A | Outer Diameter 95 mm | In distribution |
| D | Width 12 mm | In distribution |
| 0 | Height 18 mm | In distribution |
| D | Width 16 mm | In distribution |
| A | In distribution | |
| B | Width 16 mm | In distribution |
| A | Width 20 mm | In distribution |
| A | In distribution | |
| D | Width 14 mm | In distribution |
| B | Height 20 mm | In distribution |
| 0 | Height 16 mm | In distribution |
| D | Width 16 mm | In distribution |
| D | Width 16 mm | In distribution |
| G | Height 22 mm | In distribution |
| 0 | In distribution | |
| A | Height 18 mm | In distribution |
| G | Height 20 mm | In distribution |
| 0 | Width 42 mm | In distribution |
| A | Width 18 mm | In distribution |
| B | Outer Diameter 95 mm | In distribution |
| D | Width 25 mm | In distribution |
| D | Outer Diameter 100 mm | In distribution |
| B | Outer Diameter 95 mm | In distribution |
| D | Width 12 mm | 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 |
|---|---|
| K150056 | 2015-05-06 |
| K073314 | 2008-02-21 |
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.