BruxZir Esthetic
BruxZir Esthetic is a family of zirconia blanks used by dental technicians to make custom all-ceramic restorations for front and back teeth. A CAD/CAM system designs and mills the…
BruxZir Esthetic is a family of zirconia blanks used by dental technicians to make custom all-ceramic restorations for front and back teeth. A CAD/CAM system designs and mills the restoration, which is then sintered at high temperature.
The ceramic is based on yttria-stabilized zirconia, with trace colorants for different shades. Blank sizes and thicknesses vary, providing starting material for different restoration geometries.
Listed Item
BruxZir Esthetic GL Single Unit Block – Bleach White
Shade Configurations
The range includes white and pre-shaded blanks. Pre-shaded configurations are designed to achieve their target shades after sintering without an additional coloring step, while shade choices include conventional tooth colors and bleach shades.
33manufacturers in China registered for this device type
190catalogue numbers in this listing
21510(k) clearances naming this product code
1recall
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) | K213425 |
| Record published | 2021-12-22 |
| Record revised | 2024-11-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2024-11-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 70-1183-BEP0084 | In distribution | ||
| 70-1183-BEP0052 | In distribution | ||
| 70-1183-BEP0153 | In distribution | ||
| 70-1183-BEP0128 | In distribution | ||
| 70-1183-BEP0167 | In distribution | ||
| 70-1183-BEP0057 | In distribution | ||
| 70-1183-BEP0138 | In distribution | ||
| 70-1183-BEP0049 | In distribution | ||
| 70-1183-BEP0093 | In distribution | ||
| 70-1183-BEP0146 | In distribution | ||
| 70-1183-BEP0087 | In distribution | ||
| 70-1183-BEP0120 | In distribution | ||
| 70-1183-BEP0040 | In distribution | ||
| 70-1183-BEP0173 | In distribution | ||
| 70-1183-BEP0136 | In distribution | ||
| 70-1183-BEP0145 | In distribution | ||
| 70-1183-BEP0098 | In distribution | ||
| 70-1183-BEP0082 | In distribution | ||
| 70-1183-BEP0154 | In distribution | ||
| 70-1183-BEP0160 | In distribution | ||
| 70-1183-BEP0118 | In distribution | ||
| 70-1183-BEP0074 | In distribution | ||
| 70-1183-BEP0069 | In distribution | ||
| 70-1183-BEP0178 | In distribution | ||
| 70-1183-BEP0050 | In distribution | ||
| 70-1183-BEP0185 | In distribution | ||
| 70-1183-BEP0039 | In distribution | ||
| 70-1183-BEP0056 | In distribution | ||
| 70-1183-BEP0137 | In distribution | ||
| 70-1183-BEP0177 | In distribution | ||
| 70-1183-BEP0144 | In distribution | ||
| 70-1183-BEP0135 | In distribution | ||
| 70-1183-BEP0143 | In distribution | ||
| 70-1183-BEP0047 | In distribution | ||
| 70-1183-BEP0099 | In distribution | ||
| 70-1183-BEP0114 | In distribution | ||
| 70-1183-BEP0079 | In distribution | ||
| 70-1183-BEP0151 | In distribution | ||
| 70-1183-BEP0130 | In distribution | ||
| 70-1183-BEP0161 | In distribution | ||
| 70-1183-BEP0072 | In distribution | ||
| 70-1183-BEP0162 | In distribution | ||
| 70-1183-BEP0121 | In distribution | ||
| 70-1183-BEP0186 | In distribution | ||
| 70-1183-BEP0097 | In distribution | ||
| 70-1183-BEP0159 | In distribution | ||
| 70-1183-BEP0113 | In distribution | ||
| 70-1183-BEP0051 | In distribution | ||
| 70-1183-BEP0172 | In distribution | ||
| 70-1183-BEP0081 | In distribution | ||
| 70-1183-BEP0119 | In distribution | ||
| 70-1183-BEP0088 | In distribution | ||
| 70-1183-BEP0065 | In distribution | ||
| 70-1183-BEP0174 | In distribution | ||
| 70-1183-BEP0058 | In distribution | ||
| 70-1183-BEP0127 | In distribution | ||
| 70-1183-BEP0170 | In distribution | ||
| 70-1183-BEP0043 | In distribution | ||
| 70-1183-BEP0090 | In distribution | ||
| 70-1183-BEP0073 | In distribution | ||
| 70-1183-BEP0105 | In distribution | ||
| 70-1183-BEP0112 | In distribution | ||
| 70-1183-BEP0169 | In distribution | ||
| 70-1183-BEP0129 | In distribution | ||
| 70-1183-BEP0071 | In distribution | ||
| 70-1183-BEP0183 | In distribution | ||
| 70-1183-BEP0103 | In distribution | ||
| 70-1183-BEP0096 | In distribution | ||
| 70-1183-BEP0188 | In distribution | ||
| 70-1183-BEP0111 | In distribution | ||
| 70-1183-BEP0064 | In distribution | ||
| 70-1183-BEP0152 | In distribution | ||
| 70-1183-BEP0080 | In distribution | ||
| 70-1183-BEP0184 | In distribution | ||
| 70-1183-BEP0181 | In distribution | ||
| 70-1183-BEP0066 | In distribution | ||
| 70-1183-BEP0175 | In distribution | ||
| 70-1183-BEP0176 | In distribution | ||
| 70-1183-BEP0041 | In distribution | ||
| 70-1183-BEP0042 | In distribution | ||
| 70-1183-BEP0168 | In distribution | ||
| 70-1183-BEP0059 | In distribution | ||
| 70-1183-BEP0048 | In distribution | ||
| 70-1183-BEP0155 | In distribution | ||
| 70-1183-BEP0122 | In distribution | ||
| 70-1183-BEP0095 | In distribution | ||
| 70-1183-BEP0104 | In distribution | ||
| 70-1183-BEP0076 | In distribution | ||
| 70-1183-BEP0063 | In distribution | ||
| 70-1183-BEP0055 | In distribution | ||
| 70-1183-BEP0142 | In distribution | ||
| 70-1183-BEP0106 | In distribution | ||
| 70-1183-BEP0089 | In distribution | ||
| 70-1183-BEP0019 | 40 | Withdrawn | |
| 70-1183-BEP0035 | 20 | Withdrawn | |
| 70-1183-BEP0180 | Withdrawn | ||
| 70-1183-BEP0140 | Withdrawn | ||
| 70-1183-BEP0003 | 40 | Withdrawn | |
| 70-1183-BEP0101 | Withdrawn | ||
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| 70-1183-BEP0007 | 40 | Withdrawn | |
| 70-1183-BEP0015 | 40 | Withdrawn | |
| 70-1183-BEP0032 | 20 | Withdrawn | |
| 70-1183-BEP0022 | 20 | Withdrawn | |
| 70-1183-BEP0085 | Withdrawn | ||
| 70-1183-BEP0006 | 40 | Withdrawn | |
| 70-1183-BEP0045 | Withdrawn | ||
| 70-1183-BEP0033 | 20 | Withdrawn | |
| 70-1183-BEP0062 | Withdrawn | ||
| 70-1183-BEP0029 | 20 | Withdrawn | |
| 70-1183-BEP0124 | Withdrawn | ||
| 70-1183-BEP0107 | Withdrawn | ||
| 70-1183-BEP0133 | Withdrawn | ||
| 70-1183-BEP0116 | Withdrawn | ||
| 70-1183-BEP0110 | Withdrawn | ||
| 70-1183-BEP0117 | Withdrawn | ||
| 70-1183-BEP0031 | 20 | Withdrawn | |
| 70-1183-BEP0094 | Withdrawn | ||
| 70-1183-BEP0010 | 40 | Withdrawn | |
| 70-1183-BEP0002 | 40 | Withdrawn | |
| 70-1183-BEP0123 | Withdrawn | ||
| 70-1183-BEP0016 | 40 | Withdrawn | |
| 70-1183-BEP0092 | Withdrawn | ||
| 70-1183-BEP0102 | Withdrawn | ||
| 70-1183-BEP0012 | 40 | Withdrawn | |
| 70-1183-BEP0189 | Withdrawn | ||
| 70-1183-BEP0149 | Withdrawn | ||
| 70-1183-BEP0018 | 40 | Withdrawn | |
| 70-1183-BEP0091 | Withdrawn | ||
| 70-1183-BEP0038 | 20 | Withdrawn | |
| 70-1183-BEP0014 | 40 | Withdrawn | |
| 70-1183-BEP0100 | Withdrawn | ||
| 70-1183-BEP0077 | Withdrawn | ||
| 70-1183-BEP0024 | 20 | Withdrawn | |
| 70-1183-BEP0013 | 40 | Withdrawn | |
| 70-1183-BEP0005 | 40 | Withdrawn | |
| 70-1183-BEP0157 | Withdrawn | ||
| 70-1183-BEP0165 | Withdrawn | ||
| 70-1183-BEP0060 | Withdrawn | ||
| 70-1183-BEP0148 | Withdrawn | ||
| 70-1183-BEP0053 | Withdrawn | ||
| 70-1183-BEP0126 | Withdrawn | ||
| 70-1183-BEP0061 | Withdrawn | ||
| 70-1183-BEP0008 | 40 | Withdrawn | |
| 70-1183-BEP0025 | 20 | Withdrawn | |
| 70-1183-BEP0054 | Withdrawn | ||
| 70-1183-BEP0046 | Withdrawn | ||
| 70-1183-BEP0037 | 20 | Withdrawn | |
| 70-1183-BEP0044 | Withdrawn | ||
| 70-1183-BEP0026 | 20 | Withdrawn | |
| 70-1183-BEP0141 | Withdrawn | ||
| 70-1183-BEP0020 | 20 | Withdrawn | |
| 70-1183-BEP0004 | 40 | Withdrawn | |
| 70-1183-BEP0163 | Withdrawn | ||
| 70-1183-BEP0021 | 20 | Withdrawn | |
| 70-1183-BEP0156 | Withdrawn | ||
| 70-1183-BEP0131 | Withdrawn | ||
| 70-1183-BEP0067 | Withdrawn | ||
| 70-1183-BEP0034 | 20 | Withdrawn | |
| 70-1183-BEP0115 | Withdrawn | ||
| 70-1183-BEP0017 | 40 | Withdrawn | |
| 70-1183-BEP0179 | Withdrawn | ||
| 70-1183-BEP0171 | Withdrawn | ||
| 70-1183-BEP0023 | 20 | Withdrawn | |
| 70-1183-BEP0134 | Withdrawn | ||
| 70-1183-BEP0187 | Withdrawn | ||
| 70-1183-BEP0086 | Withdrawn | ||
| 70-1183-BEP0070 | Withdrawn | ||
| 70-1183-BEP0164 | Withdrawn | ||
| 70-1183-BEP0078 | Withdrawn | ||
| 70-1183-BEP0068 | Withdrawn | ||
| 70-1183-BEP0132 | Withdrawn | ||
| 70-1183-BEP0109 | Withdrawn | ||
| 70-1183-BEP0075 | Withdrawn | ||
| 70-1183-BEP0139 | Withdrawn | ||
| 70-1183-BEP0166 | Withdrawn | ||
| 70-1183-BEP0125 | Withdrawn | ||
| 70-1183-BEP0027 | 20 | Withdrawn | |
| 70-1183-BEP0028 | 20 | Withdrawn | |
| 70-1183-BEP0182 | Withdrawn | ||
| 70-1183-BEP0011 | 40 | Withdrawn | |
| 70-1183-BEP0158 | Withdrawn | ||
| 70-1183-BEP0036 | 20 | Withdrawn | |
| 70-1183-BEP0150 | Withdrawn | ||
| 70-1183-BEP0190 | Withdrawn | ||
| 70-1183-BEP0009 | 40 | Withdrawn | |
| 70-1183-BEP0030 | 20 | Withdrawn | |
| 70-1183-BEP0083 | Withdrawn | ||
| 70-1183-BEP0147 | Withdrawn | ||
| 70-1183-BEP0001 | 40 | Withdrawn |
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.