BruxZir™ TintEFX Coloring Liquid
BruxZir TintEFX Coloring Liquid adds color to presintered zirconia dental restorations. A dental technician applies the solution by dipping the framework or using a metal-free brush, then…
BruxZir TintEFX Coloring Liquid adds color to presintered zirconia dental restorations. A dental technician applies the solution by dipping the framework or using a metal-free brush, then dries the structure and sinters it above 1,400 degrees Celsius.
The aqueous liquid contains transition-metal and lanthanide-metal salts. It can be applied to gingival, body or incisal regions to create individual coloration. The range has 14 colors, including the listed Yellow shade, for patient-specific zirconia fabrication.
Listed Item
BruxZir™ TintEFX Coloring Liquid – Yellow
Bottle and Supply
The solution is supplied nonsterile in a 175 mL bottle containing 150 mL of liquid. Its role is coloring the zirconia structure before final sintering rather than forming the restoration itself. The intended users are dental technicians working on individual patient restorations.
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 | Prismatik Dentalcraft, Inc., United States |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K231347 |
| Record published | 2023-06-23 |
| Record revised | 2023-08-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 70-1123-BRX0030 | In distribution | |
| 70-1123-BRX0041 | In distribution | |
| 70-1123-BRX0026 | In distribution | |
| 70-1123-BRX0037 | In distribution | |
| 70-1123-BRX0025 | In distribution | |
| 70-1123-BRX0035 | In distribution | |
| 70-1123-BRX0029 | In distribution | |
| 70-1123-BRX0039 | In distribution | |
| 70-1123-BRX0028 | In distribution | |
| 70-1123-BRX0038 | In distribution | |
| 70-1123-BRX0034 | In distribution | |
| 70-1123-BRX0040 | In distribution | |
| 70-1123-BRX0036 | In distribution | |
| 70-1123-BRX0027 | In distribution |
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 |
|---|---|
| K262239 | 2026-07-30 |
| K254283 | 2026-01-30 |
| K252446 | 2025-09-03 |
| K250223 | 2025-02-25 |
| K240882 | 2024-05-01 |
| K240574 | 2024-03-20 |
| K234014 | 2024-02-27 |
| K231347 | 2023-06-09 |
| K230262 | 2023-05-16 |
| K220816 | 2022-08-02 |
| K220960 | 2022-06-29 |
| K213425 | 2021-11-17 |
| K200131 | 2020-06-10 |
| K191903 | 2019-11-22 |
| K150872 | 2015-07-02 |
| K143330 | 2014-12-15 |
| K141887 | 2014-11-06 |
| K141788 | 2014-08-20 |
| K130604 | 2013-09-12 |
| K130924 | 2013-05-16 |
| K100781 | 2010-06-21 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-08-15 | Class II | Release of Material/Component prior to receiving test results | Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product | 150 units | 2016-12-23 |
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.