Deva®
2 catalogue numbers from Plus Alloy, listed by Dentsply LLC, United States, under Alloy, Other Noble Metal. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
2catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Dentsply LLC, United States |
|---|---|
| FDA product code | EJS |
| Device type | Alloy, Other Noble Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3060 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-01-31 |
| Record revised | 2022-05-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| Sizes | Weight 31.1 g |
| Distribution end date | 2022-05-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Plus Alloy | Weight 31.1 g | Withdrawn |
| 4 Alloy | Weight 31.1 g | Withdrawn |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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K913860 | 1991-11-13 |
| K913232 | 1991-09-06 |
| K760783 | 1976-10-15 |
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.