Zimmer ZFX Component
8 catalogue numbers from INLAYZR, listed by ZimVie US Corp LLC, United States, under Powder, Porcelain. 33 manufacturers in China are registered for this product code.
33manufacturers in China registered for this device type
8catalogue 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 | ZimVie US Corp LLC, 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, Exporter |
| 510(k) | K093748 |
| Record published | 2015-10-23 |
| Record revised | 2026-01-15 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| INLAYZR | In distribution | |
| COPANAEMAX | In distribution | |
| CROWNEMAX | In distribution | |
| TELEZR | In distribution | |
| COPINGZR | In distribution | |
| FBRIDGEZR | In distribution | |
| VENEERZR | In distribution | |
| CROWNZR | 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
Recalls Naming This Product
10 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ivoclar Vivadent, Inc. | 510(k) number | 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. | 510(k) number | 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. | 510(k) number | 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. | 510(k) number | 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. | 510(k) number | 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. | 510(k) number | 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 | |
| Ivoclar Vivadent, Inc. | 510(k) number | 2020-04-13 | Class II | Process control | Restorations crack during the sintering process. | 9 units | 2021-01-22 |
| Ivoclar Vivadent, Inc. | 510(k) number | 2020-04-13 | Class II | Process control | Restorations crack during the sintering process. | 332 | 2021-01-22 |
| Ivoclar Vivadent, Inc. | 510(k) number | 2020-04-13 | Class II | Process control | Restorations crack during the sintering process. | 639 units | 2021-01-22 |
| Ivoclar Vivadent, Inc. | 510(k) number | 2020-04-13 | Class II | Process control | Restorations crack during the sintering process. | 6 units | 2021-01-22 |
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.