MidiGold 55
Midigold 50 5 g
11manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (9), Hebei (1), Hong Kong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Fseven Dental Technology Zhuhai Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 18 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | 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 |
| Crown Trading (HK) Co., Limited | Hong Kong | Hong Kong | Manufacturer | 8 |
| Smart Dental CAD Solutions Limited | Zhuhai | Guangdong | Manufacturer | 8 |
| Vivi Dental Laboratory | Shenzhen | Guangdong | Manufacturer | 8 |
Record
| Listed by | Ivoclar Vivadent, Inc., Canada |
|---|---|
| FDA product code | EJT |
| Device type | Alloy, Gold-Based 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 | 2018-10-29 |
| Record revised | 2022-04-27 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 583044 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jensen Premium Dental Alloy | Jensen Industries, Inc. | 77 |
| Ceramco® | Dentsply LLC | 21 |
| Windsor | Aurident, Inc. | 10 |
| RH | Aurident, Inc. | 10 |
| Elite II | Aurident, Inc. | 10 |
| Auritex WP | Aurident, Inc. | 10 |
| Auritex LP | Aurident, Inc. | 10 |
| Auritex KP | Aurident, Inc. | 10 |
| Auribond 97 | Aurident, Inc. | 10 |
| EH | Aurident, Inc. | 10 |
| Auritex 66 | Aurident, Inc. | 10 |
| WH | Aurident, Inc. | 10 |
Showing 12 of 398. All products under Alloy, Gold-Based Noble Metal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K032715 | 2003-09-26 |
| K032493 | 2003-09-04 |
| K030436 | 2003-04-15 |
| K030435 | 2003-04-15 |
| K022969 | 2002-10-18 |
| K022811 | 2002-10-09 |
| K021892 | 2002-07-25 |
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.