Ney®
18 Gauge Round
12manufacturers in China registered for this device type
1catalogue number
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 |
| Premarket notification | Exempt |
| Record published | 2017-01-31 |
| Record revised | 2022-05-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 30.5 cm |
| Distribution end date | 2022-05-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Elastic #12 Platinum Color Wire | Length 30.5 cm | Withdrawn |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.