Sterngold S
High Noble. Ceramic alloy. This is the most noble (thus the most inert) alloy ever offered in the market, 90% gold and 10% platinum. Like our Bio-C, this alloy is soft with a low melting…
High Noble. Ceramic alloy. This is the most noble (thus the most inert) alloy ever offered in the market, 90% gold and 10% platinum. Like our Bio-C, this alloy is soft with a low melting range. It can be used for full-metal as well as ceramic restorations, but is not recommended for bridges. Sterngold’s Bio Alloys were developed for those patients who are allergic to conventional dental alloys. To permit restorations to be as inert as possible in the oral cavity, Bio Alloys maximize gold and platinum content (the two most noble elements) and avoid as much as possible those noble elements that are lower in the electromotive series.
Who Else Makes It
Concentrated in Guangdong (5), Hebei (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Fseven Dental Technology Zhuhai Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 18 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Shen FU Arts LAB | Shen Zhen | Guangdong | Manufacturer | 15 |
| Shenzhen HLD Dental&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 14 |
| Shenzhen Times Dental LAB | Shenzhen | Guangdong | Manufacturer | 13 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 11 |
| Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. | Zhangzhou | Henan | Manufacturer | 6 |
| Sunrise Dental Laboratory, Ltd. | Kowloon | Hong Kong | Manufacturer | 5 |
| Liaoning Xinaite Technology Co., Ltd. | Benxi | Liaoning | Manufacturer | 3 |
| Hunan Ceramaster Material Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 2 |
Record
| Listed by | Sterngold Dental LLC, United States |
|---|---|
| FDA product code | EJS |
| Device type | Alloy, Other Noble Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3060 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-02-15 |
| Record revised | 2023-07-27 (version 2) |
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 | 2023-07-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1128386 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jensen Premium Dental Alloy | Jensen Industries, Inc. | 37 |
| Leone SPA | Leone SPA | 13 |
| Auritex ZP | Aurident, Inc. | 10 |
| Vision | Aurident, Inc. | 10 |
| YX | Aurident, Inc. | 10 |
| Vanguard | Aurident, Inc. | 10 |
| HH | Aurident, Inc. | 10 |
| KH | Aurident, Inc. | 10 |
| Marathon | Aurident, Inc. | 10 |
| Triumph | Aurident, Inc. | 10 |
| Focus | Aurident, Inc. | 10 |
| JX | Aurident, Inc. | 10 |
Showing 12 of 141. All products under Alloy, Other Noble Metal
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.