Jensen ECO Zirconia
2 catalogue numbers from Jensen ECO Zr Unshaded 12mm Frame 2pk, listed by Jensen Industries, Inc., United States, under Teeth, Porcelain. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Sichuan (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Xiao Fei Dental Manufacture (Chengdu) Co., Ltd. | Chengdu | Sichuan | Remanufacturer | 5 |
| Hangzhou Thales Medtech Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 3 |
Record
| Listed by | Jensen Industries, Inc., United States |
|---|---|
| FDA product code | ELL |
| Device type | Teeth, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3920 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2024-03-29 (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 |
| Distribution end date | 2018-05-09 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Jensen ECO Zr Unshaded 12mm Frame 2pk | 2 | In distribution | |
| Jensen ECO Zr Unshaded 15.4mm Frame 2pk | 2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioform® VF Porcelain Anteriors | Dentsply LLC | 1,050 |
| Bioblend® Porcelain Anteriors | Dentsply LLC | 696 |
| New Hue® VF Porcelain Anteriors | Dentsply LLC | 240 |
| Physioset CT | Candulor, AG | 236 |
| Bioform® VF 33 Deg. Porcelain Posteriors | Dentsply LLC | 182 |
| Bioform® VF 20 Deg. Porcelain Posteriors | Dentsply LLC | 144 |
| NobelProcera® | Nobel Biocare AB | 112 |
| Bioform® VF Rational Porcelain Posts | Dentsply LLC | 84 |
| Bonartic CT | Candulor, AG | 80 |
| Condyloform CT | Candulor, AG | 71 |
| Bioform® VF Functional Porcelain Posts | Dentsply LLC | 56 |
| Duo:PCH® | DEN-MAT Holdings, LLC | 29 |
Showing 12 of 25. All products under Teeth, Porcelain
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.