Teeth, Porcelain
Ceramic Cop Easy Ab Eng Ø6mm/Bmk Syst WP
3manufacturers in China registered for this device type
2catalogue numbers in this listing
5510(k) clearances naming this product code
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 | Nobel Biocare AB, Sweden |
|---|---|
| FDA product code | ELL |
| Device type | Teeth, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3920 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-09-17 |
| Record revised | 2019-05-31 (version 4) |
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 |
| Distribution end date | 2018-03-14 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30671 | Withdrawn | |
| 29481 | Withdrawn |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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162043 | 2016-11-22 |
| K153534 | 2016-06-06 |
| K071182 | 2007-07-11 |
| K041283 | 2004-05-28 |
| K032562 | 2004-02-06 |
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.