IPS E.max ZirCAD
IPS e.max ZirCAD LT 1 98.5-16mm/1, IPS e.max ZirCAD MT A2 98.5-14mm/1, IPS e.max ZirCAD MT Multi A2 98.5-16mm/1, IPS Ivocolor Shade Dentin SD2, Incisal Sl2, Glaze Paste FLUO, IPS Ivocolor…
IPS e.max ZirCAD LT 1 98.5-16mm/1, IPS e.max ZirCAD MT A2 98.5-14mm/1, IPS e.max ZirCAD MT Multi A2 98.5-16mm/1, IPS Ivocolor Shade Dentin SD2, Incisal Sl2, Glaze Paste FLUO, IPS Ivocolor Mixing Liquid allround
33manufacturers in China registered for this device type
972catalogue numbers in this listing
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 | Ivoclar Vivadent Aktiengesellschaft |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Record published | 2023-03-07 |
| Record revised | 2021-09-01 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2024-11-27 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 686820 | In distribution | ||
| 626591 | 5 | In distribution | |
| 686878 | In distribution | ||
| 686839 | In distribution | ||
| 686840 | In distribution | ||
| 697458 | In distribution | ||
| 742271 | In distribution | ||
| 694517 | In distribution | ||
| 686884 | In distribution | ||
| 608507 | In distribution | ||
| 686930 | In distribution | ||
| 686824 | In distribution | ||
| 686952 | In distribution | ||
| 696430 | In distribution | ||
| 686847 | In distribution | ||
| 686225 | 3 | In distribution | |
| 742266 | In distribution | ||
| 686855 | In distribution | ||
| 686216 | 5 | In distribution | |
| 686872 | In distribution | ||
| 686805 | In distribution | ||
| 742230 | In distribution | ||
| 686825 | In distribution | ||
| 752125 | In distribution | ||
| 689527 | In distribution | ||
| 686822 | In distribution | ||
| 687595 | In distribution | ||
| 686838 | In distribution | ||
| 689544 | In distribution | ||
| 686937 | In distribution | ||
| 752100 | In distribution | ||
| 696438 | In distribution | ||
| 694634 | 3 | In distribution | |
| 697467 | In distribution | ||
| 689540 | In distribution | ||
| 689530 | In distribution | ||
| 752107 | In distribution | ||
| 725196 | In distribution | ||
| 596826 | 3 | In distribution | |
| 608459 | 5 | In distribution | |
| 742274 | In distribution | ||
| 752099 | In distribution | ||
| 742268 | In distribution | ||
| 686192 | 5 | In distribution | |
| 725187 | In distribution | ||
| 686841 | In distribution | ||
| 686853 | In distribution | ||
| 694617 | 3 | In distribution | |
| 686193 | 5 | In distribution | |
| 694617 | In distribution | ||
| 686850 | In distribution | ||
| 689529 | In distribution | ||
| 608499 | In distribution | ||
| 697458 | In distribution | ||
| 608450 | 5 | In distribution | |
| 686223 | 5 | In distribution | |
| 694614 | In distribution | ||
| 689501 | In distribution | ||
| 686230 | 3 | In distribution | |
| 686227 | 3 | In distribution | |
| 725178 | In distribution | ||
| 686861 | In distribution | ||
| 697475 | In distribution | ||
| 752116 | In distribution | ||
| 686791 | In distribution | ||
| 694537 | 3 | In distribution | |
| 689512 | In distribution | ||
| 697473 | In distribution | ||
| 694531 | 5 | In distribution | |
| 602439 | 5 | In distribution | |
| 686833 | In distribution | ||
| 697459 | In distribution | ||
| 758441 | 3 | In distribution | |
| 689505 | In distribution | ||
| 725196 | In distribution | ||
| 686807 | In distribution | ||
| 752113 | In distribution | ||
| 686875 | In distribution | ||
| 689532 | In distribution | ||
| 725180 | In distribution | ||
| 752126 | In distribution | ||
| 689520 | In distribution | ||
| 689525 | In distribution | ||
| 686806 | In distribution | ||
| 686807 | In distribution | ||
| 686833 | In distribution | ||
| 686934 | In distribution | ||
| 686885 | In distribution | ||
| 725170 | In distribution | ||
| 689516 | In distribution | ||
| 689545 | In distribution | ||
| 689518 | In distribution | ||
| 697459 | In distribution | ||
| 697464 | In distribution | ||
| 686806 | In distribution | ||
| 608467 | 3 | In distribution | |
| 689539 | In distribution | ||
| 689525 | In distribution | ||
| 605453 | In distribution | ||
| 694622 | In distribution | ||
| 686880 | In distribution | ||
| 686815 | In distribution | ||
| 725188 | In distribution | ||
| 689515 | In distribution | ||
| 725198 | In distribution | ||
| 686859 | In distribution | ||
| 725177 | In distribution | ||
| 689523 | In distribution | ||
| 689541 | In distribution | ||
| 752097 | In distribution | ||
| 742271 | In distribution | ||
| 686830 | In distribution | ||
| 694541 | 3 | In distribution | |
| 686831 | In distribution | ||
| 689504 | In distribution | ||
| 686894 | In distribution | ||
| 686823 | In distribution | ||
| 689505 | In distribution | ||
| 605469 | In distribution | ||
| 689515 | In distribution | ||
| 596825 | 5 | In distribution | |
| 686924 | In distribution | ||
| 686888 | In distribution | ||
| 686902 | In distribution | ||
| 694627 | In distribution | ||
| 686206 | 3 | In distribution | |
| 694623 | In distribution | ||
| 686905 | In distribution | ||
| 752133 | In distribution | ||
| 742274 | In distribution | ||
| 689534 | In distribution | ||
| 686863 | In distribution | ||
| 697496 | In distribution | ||
| 689533 | In distribution | ||
| 702929 | In distribution | ||
| 686946 | In distribution | ||
| 686840 | In distribution | ||
| 697479 | In distribution | ||
| 608458 | 5 | In distribution | |
| 725203 | In distribution | ||
| 686788 | In distribution | ||
| 686867 | In distribution | ||
| 697488 | In distribution | ||
| 742258 | In distribution | ||
| 694523 | In distribution | ||
| 752108 | In distribution | ||
| 686834 | In distribution | ||
| 697487 | In distribution | ||
| 694601 | In distribution | ||
| 694521 | 5 | In distribution | |
| 686890 | In distribution | ||
| 686204 | 3 | In distribution | |
| 725193 | In distribution | ||
| 697464 | In distribution | ||
| 689547 | In distribution | ||
| 686852 | In distribution | ||
| 686828 | In distribution | ||
| 725199 | In distribution | ||
| 689548 | In distribution | ||
| 602442 | 3 | In distribution | |
| 725171 | In distribution | ||
| 686794 | In distribution | ||
| 696442 | In distribution | ||
| 686195 | 5 | In distribution | |
| 686879 | In distribution | ||
| 686887 | In distribution | ||
| 752105 | In distribution | ||
| 686204 | 3 | In distribution | |
| 686799 | In distribution | ||
| 686849 | In distribution | ||
| 725195 | In distribution | ||
| 686857 | In distribution | ||
| 694547 | 3 | In distribution | |
| 697460 | In distribution | ||
| 686203 | 3 | In distribution | |
| 725192 | In distribution | ||
| 742273 | In distribution | ||
| 686787 | In distribution | ||
| 626589 | 5 | In distribution | |
| 602439 | 5 | In distribution | |
| 696433 | In distribution | ||
| 689543 | In distribution | ||
| 697484 | In distribution | ||
| 686851 | In distribution | ||
| 686940 | In distribution | ||
| 694554 | 3 | In distribution | |
| 686218 | 5 | In distribution | |
| 752121 | In distribution | ||
| 686820 | In distribution | ||
| 752101 | In distribution | ||
| 686845 | In distribution | ||
| 752151 | In distribution | ||
| 725208 | In distribution | ||
| 689526 | In distribution | ||
| 697490 | In distribution | ||
| 686928 | In distribution | ||
| 752106 | In distribution | ||
| 686856 | In distribution | ||
| 605453 | In distribution | ||
| 694522 | In distribution | ||
| 725216 | In distribution | ||
| 725201 | In distribution | ||
| 686790 | In distribution | ||
| 758436 | 3 | In distribution | |
| 686231 | 3 | In distribution | |
| 608507 | In distribution | ||
| 725194 | In distribution | ||
| 752141 | In distribution | ||
| 725202 | In distribution | ||
| 686845 | In distribution | ||
| 697491 | In distribution | ||
| 686944 | In distribution | ||
| 686952 | In distribution | ||
| 686813 | In distribution | ||
| 686901 | In distribution | ||
| 686812 | In distribution | ||
| 752109 | In distribution | ||
| 686886 | In distribution | ||
| 742257 | In distribution | ||
| 686217 | 5 | In distribution | |
| 686875 | In distribution | ||
| 689514 | In distribution | ||
| 694526 | In distribution | ||
| 686848 | In distribution | ||
| 725205 | In distribution | ||
| 686196 | 5 | In distribution | |
| 686791 | In distribution | ||
| 686222 | 5 | In distribution | |
| 742272 | In distribution | ||
| 742261 | In distribution | ||
| 686852 | In distribution | ||
| 752127 | In distribution | ||
| 686809 | In distribution | ||
| 686830 | In distribution | ||
| 752149 | In distribution | ||
| 686216 | 5 | In distribution | |
| 686907 | In distribution | ||
| 694621 | 3 | In distribution | |
| 686870 | In distribution | ||
| 694634 | In distribution | ||
| 686864 | In distribution | ||
| 752144 | In distribution | ||
| 686225 | 3 | In distribution | |
| 694523 | 5 | In distribution | |
| 694611 | In distribution | ||
| 686891 | In distribution | ||
| 697487 | In distribution | ||
| 689547 | In distribution | ||
| 697485 | In distribution | ||
| 686938 | 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
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Ivoclar Vivadent, Inc. | UDI-DI | 2024-04-05 | Class II | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration | 2286 units |
| Ivoclar Vivadent, Inc. | UDI-DI | 2024-04-05 | Class II | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration | 7445 units |
| Ivoclar Vivadent, Inc. | UDI-DI | 2024-04-05 | Class II | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration | 11330 units |
| Ivoclar Vivadent, Inc. | UDI-DI | 2024-04-05 | Class II | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration | 12525 units |
| Ivoclar Vivadent, Inc. | UDI-DI | 2024-04-05 | Class II | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration | 4080 units |
| Ivoclar Vivadent, Inc. | UDI-DI | 2024-04-05 | Class II | Under Investigation by firm | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration | 2472 units |
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.