Estar-ZE
Estar-ZE provides zirconia blanks in both disc and block formats for CAD/CAM dental restorations. The prefabricated, partially sintered ceramic is milled and then furnace-sintered to form…
Estar-ZE provides zirconia blanks in both disc and block formats for CAD/CAM dental restorations. The prefabricated, partially sintered ceramic is milled and then furnace-sintered to form the final polycrystalline restoration.
The material is yttrium-stabilized zirconium oxide. Uses include inlays, artificial teeth, crowns and bridges, with blank shape selected for the milling equipment and restoration design.
Formats and Shades
Disc blanks are 98 mm in diameter and 10 to 30 mm high; block formats provide additional height and length combinations. The range includes uniform and gradation tooth shades using different colouring additives. Both formats are supplied nonsterile and require final sintering after milling.
33manufacturers in China registered for this device type
298catalogue 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 | Osstem Implant Co., Ltd., South Korea |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K242521 |
| Record published | 2024-12-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZEHTA2018M | In distribution | |
| ZEHTB2014T | In distribution | |
| ZEHTA0012T | In distribution | |
| ZEHTA3020T | In distribution | |
| ZEHTD4025T | In distribution | |
| ZEHTB2012M | In distribution | |
| ZEHTD4018T | In distribution | |
| ZEHTD3018M | In distribution | |
| ZEHTD2020M | In distribution | |
| ZEHTB3020T | In distribution | |
| ZEHTD3016M | In distribution | |
| ZEHTB4012T | In distribution | |
| ZEHTD2012M | In distribution | |
| ZEHTA0025T | In distribution | |
| ZEHTC2018T | In distribution | |
| ZEHTA0016T | In distribution | |
| ZEHTA2010T | In distribution | |
| ZEHTA4025T | In distribution | |
| ZEHTB2030T | In distribution | |
| ZEHTC1022T | In distribution | |
| ZEHTC4014M | In distribution | |
| ZEHTC4012T | In distribution | |
| ZEHTA3520T | In distribution | |
| ZEHTA1030T | In distribution | |
| ZEHTB2030M | In distribution | |
| ZEHTD3030T | In distribution | |
| ZEHTC2012M | In distribution | |
| ZEHTD4010T | In distribution | |
| ZEHTD4010M | In distribution | |
| ZEHTB2025T | In distribution | |
| ZEHTA1022M | In distribution | |
| ZEHTB3020M | In distribution | |
| ZEHTD3025M | In distribution | |
| ZEHTC2016M | In distribution | |
| ZEHTC2018M | In distribution | |
| ZEHTC1012T | In distribution | |
| ZEHTB1010M | In distribution | |
| ZEHTC3016M | In distribution | |
| ZEHTC3020M | In distribution | |
| ZEHTC1010T | In distribution | |
| ZEHTA4016T | In distribution | |
| ZEHTC3010T | In distribution | |
| ZEHTC3014T | In distribution | |
| ZEHTB2010T | In distribution | |
| ZEHTD2018M | In distribution | |
| ZEHTB3014T | In distribution | |
| ZEHTD3022M | In distribution | |
| ZEHTD2014M | In distribution | |
| ZEHTA2030T | In distribution | |
| ZEHTC1025T | In distribution | |
| ZEHTB1018T | In distribution | |
| ZEHTA3012M | In distribution | |
| ZEHTB3012M | In distribution | |
| ZEHTA1030M | In distribution | |
| ZEHTC4020T | In distribution | |
| ZEHTA2022T | In distribution | |
| ZEHTA3525T | In distribution | |
| ZEHTA4020M | In distribution | |
| ZEHTC2012T | In distribution | |
| ZEHTC1020T | In distribution | |
| ZEHTA2030M | In distribution | |
| ZEHTC1025M | In distribution | |
| ZEHTD3016T | In distribution | |
| ZEHTB4016M | In distribution | |
| ZEHTC4010T | In distribution | |
| ZEHTD3012M | In distribution | |
| ZEHTB1016M | In distribution | |
| ZEHTA0030T | In distribution | |
| ZEHTC3014M | In distribution | |
| ZEHTC2030T | In distribution | |
| ZEHTB3010M | In distribution | |
| ZEHTA1025M | In distribution | |
| ZEHTS4018T | In distribution | |
| ZEHTA3018T | In distribution | |
| ZEHTD2030T | In distribution | |
| ZEHTC4020M | In distribution | |
| ZEHTC3018T | In distribution | |
| ZEHTB3025M | In distribution | |
| ZEHTC2022M | In distribution | |
| ZEHTC1030T | In distribution | |
| ZEHTB2022M | In distribution | |
| ZEHTB3018T | In distribution | |
| ZEHTA1022T | In distribution | |
| ZEHTD2025T | In distribution | |
| ZEHTC3030M | In distribution | |
| ZEHTA1018T | In distribution | |
| ZEHTB1016T | In distribution | |
| ZEHTA1016T | In distribution | |
| ZEHTA1014M | In distribution | |
| ZEHTB3022M | In distribution | |
| ZEHTC3016T | In distribution | |
| ZEHTA4018T | In distribution | |
| ZEHTA3012T | In distribution | |
| ZEHTB4025M | In distribution | |
| ZEHTA4018M | In distribution | |
| ZEHTB3030M | In distribution | |
| ZEHTC4018M | In distribution | |
| ZEHTD2010M | In distribution | |
| ZEHTD4016T | In distribution | |
| ZEHTB3014M | In distribution | |
| ZEHTA3014T | In distribution | |
| ZEHTB1012M | In distribution | |
| ZEHTC4025T | In distribution | |
| ZEHTB1014T | In distribution | |
| ZEHTD2016T | In distribution | |
| ZEHTB2018M | In distribution | |
| ZEHTA3522M | In distribution | |
| ZEHTC1022M | In distribution | |
| ZEHTA3516T | In distribution | |
| ZEHTD2030M | In distribution | |
| ZEHTA0022T | In distribution | |
| ZEHTA4025M | In distribution | |
| ZEHTA3030T | In distribution | |
| ZEHTD2012T | In distribution | |
| ZEHTD3030M | In distribution | |
| ZEHTB2022T | In distribution | |
| ZEHTA3510T | In distribution | |
| ZEHTD4014T | In distribution | |
| ZEHTC2025M | In distribution | |
| ZEHTA3025M | In distribution | |
| ZEHTA1018M | In distribution | |
| ZEHTC4016M | In distribution | |
| ZEHTC1018T | In distribution | |
| ZEHTC4022M | In distribution | |
| ZEHTA4010M | In distribution | |
| ZEHTC1010M | In distribution | |
| ZEHTA3020M | In distribution | |
| ZEHTA2014T | In distribution | |
| ZEHTB4016T | In distribution | |
| ZEHTB2016M | In distribution | |
| ZEHTB1014M | In distribution | |
| ZEHTA0020T | In distribution | |
| ZEHTD2014T | In distribution | |
| ZEHTB2012T | In distribution | |
| ZEHTA1010M | In distribution | |
| ZEHTA4022T | In distribution | |
| ZEHTD4025M | In distribution | |
| ZEHTC1014M | In distribution | |
| ZEHTB4010M | In distribution | |
| ZEHTA3522T | In distribution | |
| ZEHTD3018T | In distribution | |
| ZEHTC2010M | In distribution | |
| ZEHTC2020T | In distribution | |
| ZEHTA3510M | In distribution | |
| ZEHTD2025M | In distribution | |
| ZEHTA3010M | In distribution | |
| ZEHTC3030T | In distribution | |
| ZEHTA4014M | In distribution | |
| ZEHTB4022M | In distribution | |
| ZEHTA3022T | In distribution | |
| ZEHTA3514T | In distribution | |
| ZEHTC3018M | In distribution | |
| ZEHTA1020M | In distribution | |
| ZEHTC1018M | In distribution | |
| ZEHTA4012T | In distribution | |
| ZEHTA1014T | In distribution | |
| ZEHTB1025M | In distribution | |
| ZEHTA3525M | In distribution | |
| ZEHTB2014M | In distribution | |
| ZEHTD2020T | In distribution | |
| ZEHTA3018M | In distribution | |
| ZEHTB4030T | In distribution | |
| ZEHTA3530T | In distribution | |
| ZEHTB2020M | In distribution | |
| ZEHTA2012M | In distribution | |
| ZEHTA4020T | In distribution | |
| ZEHTB4025T | In distribution | |
| ZEHTA2022M | In distribution | |
| ZEHTC3012M | In distribution | |
| ZEHTC4030M | In distribution | |
| ZEHTA3030M | In distribution | |
| ZEHTA4030T | In distribution | |
| ZEHTA2025T | In distribution | |
| ZEHTA3520M | In distribution | |
| ZEHTA0018T | In distribution | |
| ZEHTD4022T | In distribution | |
| ZEHTB4030M | In distribution | |
| ZEHTB1030M | In distribution | |
| ZEHTA0010T | In distribution | |
| ZEHTC4018T | In distribution | |
| ZEHTB1010T | In distribution | |
| ZEHTB4020M | In distribution | |
| ZEHTB4018T | In distribution | |
| ZEHTB4018M | In distribution | |
| ZEHTB3016M | In distribution | |
| ZEHTA2016T | In distribution | |
| ZEHTC2022T | In distribution | |
| ZEHTD4022M | In distribution | |
| ZEHTC4030T | In distribution | |
| ZEHTB1012T | In distribution | |
| ZEHTD4030T | In distribution | |
| ZEHTC1014T | In distribution | |
| ZEHTD3014M | In distribution | |
| ZEHTC1016M | In distribution | |
| ZEHTD4018M | In distribution | |
| ZEHTD3022T | In distribution | |
| ZEHTC3012T | In distribution | |
| ZEHTA4012M | In distribution | |
| ZEHTC3022T | In distribution | |
| ZEHTC1012M | In distribution | |
| ZEHTA3518M | In distribution | |
| ZEHTB1025T | In distribution | |
| ZEHTD3012T | In distribution | |
| ZEHTA3010T | In distribution | |
| ZEHTD2022M | In distribution | |
| ZEHTC2014T | In distribution | |
| ZEHTA2025M | In distribution | |
| ZEHTD4020M | In distribution | |
| ZEHTB4014M | In distribution | |
| ZEHTB1022M | In distribution | |
| ZEHTA3514M | In distribution | |
| ZEHTD4016M | In distribution | |
| ZEHTA4030M | In distribution | |
| ZEHTC4010M | In distribution | |
| ZEHTC1016T | In distribution | |
| ZEHTA2014M | In distribution | |
| ZEHTD4030M | In distribution | |
| ZEHTA4022M | In distribution | |
| ZEHTA3516M | In distribution | |
| ZEHTC2030M | In distribution | |
| ZEHTA1012M | In distribution | |
| ZEHTC4022T | In distribution | |
| ZEHTA2020M | In distribution | |
| ZEHTB2018T | In distribution | |
| ZEHTB2010M | In distribution | |
| ZEHTD2018T | In distribution | |
| ZEHTD3020T | In distribution | |
| ZEHTC3020T | In distribution | |
| ZEHTC2014M | In distribution | |
| ZEHTA1025T | In distribution | |
| ZEHTA1010T | In distribution | |
| ZEHTA3518T | In distribution | |
| ZEHTA3512M | In distribution | |
| ZEHTD3010T | In distribution | |
| ZEHTD4012M | In distribution | |
| ZEHTC4025M | In distribution | |
| ZEHTC4014T | In distribution | |
| ZEHTB4014T | In distribution | |
| ZEHTD3020M | In distribution | |
| ZEHTB3016T | In distribution | |
| ZEHTD3025T | In distribution | |
| ZEHTC2010T | In distribution | |
| ZEHTB1020T | In distribution | |
| ZEHTA4016M | In distribution | |
| ZEHTB2016T | In distribution | |
| ZEHTC1020M | In distribution | |
| ZEHTB3010T | In distribution | |
| ZEHTD2010T | In distribution | |
| ZEHTC3025T | In distribution | |
| ZEHTB4010T | In distribution |
Showing 250 of 298 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 |
|---|---|
| K242521 | 2024-11-20 |
| K210097 | 2021-07-02 |
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.