LCW.3MM Spool
Catalogue number 584135, listed by Ivoclar Vivadent, Inc., Canada, under Alloy, Gold-Based Noble Metal. 11 manufacturers in China are registered for this product code.
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 |
| Record published | 2017-01-27 |
| Record revised | 2019-02-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2018-11-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 584135 | Withdrawn |
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.