Jensen XT Zirconia
96 catalogue numbers from Jensen XT Zr Unshaded 20mm Frames 2pk, listed by Jensen Industries, Inc., United States, under Powder, Porcelain. 33 manufacturers in China are registered for this product code.
33manufacturers in China registered for this device type
96catalogue numbers in this listing
11510(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 | Jensen Industries, Inc., United States |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K112806 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-24 (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 | 2022-11-14 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Jensen XT Zr Unshaded 20mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr A1 12mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr A1 98x12mm Disc | In distribution | ||
| Jensen XT Zr D2 98x18mm Disc | In distribution | ||
| Jensen XT Zr Unshaded 98x18mm Disc | In distribution | ||
| Jensen XT Zr B1 98x12mm Disc | In distribution | ||
| Jensen XT Zr A1 20mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr A1 98x18mm Disc | In distribution | ||
| Jensen XT Zr A3 14mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr A2 14mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr D2 98x14mm Disc | In distribution | ||
| Jensen XT Zr A4 98x14mm Disc | In distribution | ||
| Jensen XT Zr A1 98x14mm Disc | In distribution | ||
| Jensen XT Zr A2 20mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr B1 12mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr B1 98x18mm Disc | In distribution | ||
| Jensen XT Zr C2 98x18mm Disc | In distribution | ||
| Jensen XT Zr B3 98x14mm Disc | In distribution | ||
| Jensen XT Zr Unshaded 98x14mm Disc | In distribution | ||
| Jensen XT Zr A2 98x14mm Disc | In distribution | ||
| Jensen XT Zr D2 98x12mm Disc | In distribution | ||
| Jensen XT Zr A2 12mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr A3.5 98x14mm Disc | In distribution | ||
| Jensen XT Zr A1 14mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr Unshaded 24.5mm Frame 2pk | 2 | In distribution | |
| Jensen XT Zr Unshaded 15.4mm Frame 2pk | 2 | In distribution | |
| Jensen XT Zr OM1 98x14mm Disc | In distribution | ||
| Jensen XT Zr A3 98x18mm Disc | In distribution | ||
| Jensen XT Zr D4 98x14mm Disc | In distribution | ||
| Jensen XT Zr OM3 98x14mm Disc | In distribution | ||
| Jensen XT Zr C4 98x14mm Disc | In distribution | ||
| Jensen XT Zr D2 20mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr Unshaded 98x12mm Disc | In distribution | ||
| Jensen XT Zr A3.5 98x18mm Disc | In distribution | ||
| Jensen XT Zr A2 98x12mm Disc | In distribution | ||
| Jensen XT Zr D2 14mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr B1 20mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr C2 20mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr Unshaded 12mm Frame 2pk | 2 | In distribution | |
| Jensen XT Zr OM2 98x14mm Disc | In distribution | ||
| Jensen XT Zr B1 98x14mm Disc | In distribution | ||
| Jensen XT Zr A3 98x14mm Disc | In distribution | ||
| Jensen XT Zr Unshaded 14mm Frame 2pk | 2 | In distribution | |
| Jensen XT Zr B4 98x14mm Disc | In distribution | ||
| Jensen XT Zr Unshaded 98x25mm Disc | In distribution | ||
| Jensen XT Zr C2 98x14mm Disc | In distribution | ||
| Jensen XT Zr D3 98x14mm Disc | In distribution | ||
| Jensen XT Zr D2 12mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr C3 98x14mm Disc | In distribution | ||
| Jensen XT Zr C2 12mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr A3 20mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr C3 98x18mm Disc | In distribution | ||
| Jensen XT Zr Unshaded 98x10mm Disc | In distribution | ||
| Jensen XT Zr A3 12mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr B2 98x18mm Disc | In distribution | ||
| Jensen XT Zr C2 98x12mm Disc | In distribution | ||
| Jensen XT Zr A2 98x18mm Disc | In distribution | ||
| Jensen XT Zr Unshaded 98x22mm Disc | In distribution | ||
| Jensen XT Zr C1 98x14mm Disc | In distribution | ||
| Jensen XT Zr A3 98x12mm Disc | In distribution | ||
| Jensen XT Zr C2 14mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr B1 14mm Frames 2pk | 2 | In distribution | |
| Jensen XT Zr B2 98x14mm Disc | In distribution | ||
| Jensen XT TRAN Zr Mono A2 98×18 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono B3 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono B1 14mm Frame 2pk | 2 | Withdrawn | |
| Jensen XT TRAN Zr Mono A3 14mm Frame 2pk | 2 | Withdrawn | |
| Jensen XT TRAN Zr Mono B2 14mm Frame 2pk | 2 | Withdrawn | |
| Jensen XT TRAN Zr Mono C2 14mm Frame 2pk | 2 | Withdrawn | |
| Jensen XT TRAN Zr Mono C3 14mm Frame 2pk | 2 | Withdrawn | |
| Jensen XT TRAN Zr Mono C2 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono A3.5 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono B4 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono C3 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono D3 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono D2 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono B1 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono A4 14mm Frame 2pk | 2 | Withdrawn | |
| Jensen XT TRAN Zr Mono B2 98×18 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono A2 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono D3 14mm Frame 2pk | 2 | Withdrawn | |
| Jensen XT TRAN Zr Mono A1 14mm Frame 2pk | 2 | Withdrawn | |
| Jensen XT TRAN Zr Mono C1 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono D4 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono A3.5 14mm Frame 2pk | 2 | Withdrawn | |
| Jensen XT TRAN Zr Mono C1 98×18 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono B1 98×18 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono A4 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono C2 98×18 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono C4 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono C1 14mm Frame 2pk | 2 | Withdrawn | |
| Jensen XT TRAN Zr Mono A3 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono B2 98×14 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono A2 14mm Frame 2pk | 2 | Withdrawn | |
| Jensen XT TRAN Zr Mono A3 98×18 Disc | Withdrawn | ||
| Jensen XT TRAN Zr Mono A1 98×14 Disc | 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 |
|---|---|
| K183408 | 2019-03-20 |
| K142043 | 2014-12-18 |
| K112806 | 2011-12-01 |
| K111743 | 2011-09-14 |
| K070114 | 2007-03-01 |
| K050838 | 2005-05-04 |
| K043201 | 2005-01-11 |
| K043221 | 2004-12-20 |
| K002904 | 2000-11-06 |
| K002041 | 2000-08-16 |
| K981490 | 1998-10-22 |
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.