Cerawhite
3 catalogue numbers from porcelain-veneer, listed by Hangzhou Thales Medtech Co., Ltd., China, under Teeth, Artificial, Posterior With Metal Insert. 14 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (5), Hong Kong (4), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Improve Co., Limited | Lantau Island | Hong Kong | Contract manufacturer | 16 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Shenzhen HLD Dental&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 14 |
| Shenzhen Times Dental LAB | Shenzhen | Guangdong | Manufacturer | 13 |
| Smile Dental Laboratory Company Limited | Zhuhai | Guangdong | Manufacturer | 11 |
| Joydenta Dental Laboratory | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Nanjing Chamlion Laser Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 7 |
| Sunstar Trading International Limited | Kowloon | Hong Kong | Manufacturer | 6 |
| Huile Denture Technology(Hongkong)Co., Limited | Hong Kong | Hong Kong | Contract manufacturer | 5 |
| Istar Dental LAB | Shenzhen | Guangdong | Manufacturer | 5 |
| Sunrise Dental Laboratory, Ltd. | Kowloon | Hong Kong | Manufacturer | 5 |
| Xiao Fei Dental Manufacture (Chengdu) Co., Ltd. | Chengdu | Sichuan | Remanufacturer | 5 |
Showing 12 of 14. All 14 manufacturers in China registered for Teeth, Artificial, Posterior With Metal Insert
Record
| Listed by | Hangzhou Thales Medtech Co., Ltd., China |
|---|---|
| FDA product code | ELJ |
| Device type | Teeth, Artificial, Posterior With Metal Insert |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3900 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-05-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| porcelain-veneer | In distribution | |
| crown/bridge | In distribution | |
| porcelain-crown/bridge | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Raydent C&B | RAY Co., Ltd., | 9 |
| Vertex-Dental BV | Vertex-Dental B.V. | 6 |
| Ceramill | Vertex-Dental B.V. | 4 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 3 |
| Mazic D Temp | Vericom Co., Ltd. | 3 |
| Lingual Bladed 1X16 33-D M A4 | American Tooth Industries | 1 |
| Lingual Bladed 1×16 33-D M Sh 59 | American Tooth Industries | 1 |
| Lingual Bladed 1X16 33-D S SH62 | American Tooth Industries | 1 |
| Lingual Bladed 1X16 20-DEG M S67 | American Tooth Industries | 1 |
| Lingual Bladed 1X16 20-DEG M A3 | American Tooth Industries | 1 |
| Lingual Bladed 1X16 33-D S A4 | American Tooth Industries | 1 |
| Lingual Bladed 1X16 33-D S B2 | American Tooth Industries | 1 |
Showing 12 of 44. All products under Teeth, Artificial, Posterior With Metal Insert
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.