ZIRento
ZIRento 16 A3.5 25mm 98mm Step - SI
33manufacturers in China registered for this device type
136catalogue 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 | Distribudent, LLC |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| 510(k) | K130924 |
| Record published | 2017-02-10 |
| Record revised | 2018-07-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Height 12 to 25 mm; height 12 to 25 µm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Z16A4-2098ST-SI | Height 20 mm | In distribution |
| Z16C2-2098ST-SI | Height 20 mm | In distribution |
| Z16C3-2098ST-SI | Height 20 mm | In distribution |
| Z16D3-1598ST | Height 15 mm | In distribution |
| Z16B3-1298ST-SI | Height 12 mm | In distribution |
| Z16C4-1598ST | Height 15 mm | In distribution |
| Z16B4-1298ST | Height 12 mm | In distribution |
| Z16C3-1298ST | Height 12 mm | In distribution |
| Z16D4-1298ST | Height 12 mm | In distribution |
| Z16B1-2098ST-SI | Height 20 µm | In distribution |
| Z16B3-1598ST-SI | Height 15 mm | In distribution |
| Z16D4-1298ST-SI | Height 12 mm | In distribution |
| Z16C2-2598ST | Height 25 mm | In distribution |
| Z16D2-2098ST | Height 20 mm | In distribution |
| Z16A3-1598ST-SI | Height 15 mm | In distribution |
| Z16A1-1298ST | Height 12 mm | In distribution |
| Z16C2-1298ST | Height 12 mm | In distribution |
| Z16A2-1298ST | Height 12 mm | In distribution |
| Z16B2-2598ST-SI | Height 25 mm | In distribution |
| Z16A35-1598ST | Height 15 mm | In distribution |
| Z16C4-2598ST-SI | Height 25 mm | In distribution |
| Z16D2-1598ST-SI | Height 15 mm | In distribution |
| Z16D4-2098ST-SI | Height 20 mm | In distribution |
| Z16C1-1298ST-SI | Height 12 mm | In distribution |
| Z16D2-2098ST-SI | Height 20 mm | In distribution |
| Z16B2-1298ST | Height 12 mm | In distribution |
| Z16A35-2098ST | Height 20 mm | In distribution |
| Z16C4-2098ST | Height 20 mm | In distribution |
| Z16A1-2598ST-SI | In distribution | |
| Z16A2-2598ST | Height 25 mm | In distribution |
| Z16D4-2098ST | Height 20 mm | In distribution |
| Z16D4-2598ST-SI | Height 25 mm | In distribution |
| Z16B4-2098ST-SI | Height 20 mm | In distribution |
| Z16C4-2098ST-SI | Height 20 µm | In distribution |
| Z16C1-1598ST-SI | Height 15 mm | In distribution |
| Z16D3-1298ST-SI | Height 12 µm | In distribution |
| Z16A35-2598ST-SI | Height 25 mm | In distribution |
| Z16A2-1598ST-SI | Height 15 mm | In distribution |
| Z16B2-2098ST | Height 20 mm | In distribution |
| ZW-2098ST | Height 20 mm | In distribution |
| Z16C2-1298ST-SI | Height 12 mm | In distribution |
| Z16C1-1298ST | Height 12 mm | In distribution |
| Z16A4-2098ST | Height 20 mm | In distribution |
| Z16C1-2598ST | Height 25 mm | In distribution |
| Z16D4-1598ST | Height 15 mm | In distribution |
| Z16B2-1298ST-SI | Height 12 mm | In distribution |
| Z16C1-2098ST | Height 20 mm | In distribution |
| Z16D3-2098ST | Height 20 mm | In distribution |
| Z16D4-2598ST | Height 25 mm | In distribution |
| Z16A35-1298ST | Height 12 mm | In distribution |
| Z16C4-1598ST-SI | Height 15 mm | In distribution |
| Z16A1-2098ST | In distribution | |
| Z16D2-2598ST-SI | Height 25 mm | In distribution |
| Z16B3-1598ST | Height 15 mm | In distribution |
| Z16C4-1298ST-SI | Height 12 mm | In distribution |
| Z16C3-1598ST-SI | In distribution | |
| Z16D2-2598ST | Height 25 mm | In distribution |
| Z16B1-2098ST | Height 20 mm | In distribution |
| Z16A35-1298ST-SI | Height 12 mm | In distribution |
| Z16C2-2598ST-SI | Height 25 mm | In distribution |
| Z16D2-1598ST | Height 15 mm | In distribution |
| Z16D3-2598ST-SI | Height 25 mm | In distribution |
| ZW-2598ST-SI | Height 25 mm | In distribution |
| Z16A1-2098ST-SI | Height 20 mm | In distribution |
| Z16A1-2598ST | Height 25 mm | In distribution |
| Z16D2-1298ST-SI | Height 12 mm | In distribution |
| Z16A3-1598ST | Height 15 mm | In distribution |
| Z16D3-2598ST | Height 25 mm | In distribution |
| Z16B1-1598ST-SI | Height 15 mm | In distribution |
| Z16A4-2598ST-SI | Height 25 mm | In distribution |
| Z16A35-2098ST-SI | Height 20 mm | In distribution |
| Z16D2-1298ST | Height 12 mm | In distribution |
| Z16B4-1598ST | Height 15 mm | In distribution |
| Z16C1-1598ST | Height 15 mm | In distribution |
| Z16C4-1298ST | Height 12 mm | In distribution |
| Z16C2-2098ST | Height 20 mm | In distribution |
| Z16C3-2598ST | Height 25 mm | In distribution |
| Z16C3-1598ST | Height 15 mm | In distribution |
| Z16B3-2598ST | Height 25 mm | In distribution |
| Z16C3-1298ST-SI | Height 12 mm | In distribution |
| Z16A4-1298ST-SI | Height 12 mm | In distribution |
| Z16D3-2098ST-SI | Height 20 µm | In distribution |
| Z16B4-1298ST-SI | Height 12 mm | In distribution |
| ZW-1298ST-SI | Height 12 mm | In distribution |
| Z16B4-2598ST-SI | Height 25 mm | In distribution |
| Z16C4-2598ST | Height 25 mm | In distribution |
| ZW-1598ST | Height 15 mm | In distribution |
| Z16A2-2098ST | Height 20 mm | In distribution |
| ZW-2598ST | Height 25 mm | In distribution |
| Z16A1-1298ST-SI | Height 12 mm | In distribution |
| Z16B2-2098ST-SI | Height 20 mm | In distribution |
| Z16D3-1298ST | Height 12 mm | In distribution |
| Z16A4-1598ST | Height 15 mm | In distribution |
| Z16D4-1598ST-SI | Height 15 mm | In distribution |
| Z16A3-2598ST | Height 25 mm | In distribution |
| Z16A3-2598ST-SI | Height 25 mm | In distribution |
| Z16A3-2098ST-SI | Height 20 mm | In distribution |
| Z16B1-1298ST | Height 12 mm | In distribution |
| ZW-1598ST-SI | Height 15 mm | In distribution |
| Z16A3-1298ST-SI | Height 12 mm | In distribution |
| Z16C1-2098ST-SI | Height 20 µm | In distribution |
| Z16C3-2098ST | Height 20 mm | In distribution |
| Z16C3-2598ST-SI | Height 25 µm | In distribution |
| Z16B2-2598ST | Height 25 mm | In distribution |
| Z16B1-1298ST-SI | Height 12 mm | In distribution |
| Z16B2-1598ST | Height 15 mm | In distribution |
| ZW-1298ST | Height 12 mm | In distribution |
| Z16B3-2098ST-SI | Height 20 mm | In distribution |
| Z16A1-1598ST-SI | Height 15 mm | In distribution |
| Z16A3-2098ST | Height 20 mm | In distribution |
| Z16B1-2598ST-SI | Height 25 mm | In distribution |
| Z16B3-2098ST | Height 20 mm | In distribution |
| Z16B4-2598ST | Height 25 mm | In distribution |
| Z16A35-2598ST | Height 25 mm | In distribution |
| Z16A35-1598ST-SI | Height 15 mm | In distribution |
| Z16B1-1598ST | Height 15 mm | In distribution |
| Z16A3-1298S | Height 12 mm | In distribution |
| Z16C1-2598ST-SI | Height 25 mm | In distribution |
| Z16A4-1598ST-SI | Height 15 mm | In distribution |
| ZW-2098ST-SI | Height 20 mm | In distribution |
| Z16A2-1598ST | Height 15 mm | In distribution |
| Z16A2-2598ST-SI | Height 25 mm | In distribution |
| Z16A2-1298ST-SI | Height 12 mm | In distribution |
| Z16B4-2098ST | Height 20 mm | In distribution |
| Z16A1-1598ST | Height 15 mm | In distribution |
| Z16B1-2598ST | Height 25 mm | In distribution |
| Z16A2-2098ST-SI | Height 20 mm | In distribution |
| Z16A4-2598ST | Height 25 mm | In distribution |
| Z16D3-1598ST-SI | Height 15 mm | In distribution |
| Z16C2-1598ST | Height 15 mm | In distribution |
| Z16B3-2598ST-SI | Height 25 mm | In distribution |
| Z16C2-1598ST-SI | In distribution | |
| Z16B4-1598ST-SI | Height 15 mm | In distribution |
| Z16A4-1298ST | Height 12 mm | In distribution |
| Z16B2-1598ST-SI | Height 15 mm | In distribution |
| Z16B3-1298ST | Height 12 mm | 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
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Prismatik Dentalcraft, Inc. | 510(k) number | 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.