Linea Tac 400m Amalgamator
Catalogue number 7004, listed by Wykle Research, Inc., United States, under Amalgamator, Dental, Ac-Powered. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
| E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 2 |
Record
| Listed by | Wykle Research, Inc., United States |
|---|---|
| FDA product code | EFD |
| Device type | Amalgamator, Dental, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3100 |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7004 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cresent® Wig-L-Bug | Dentsply LLC | 6 |
| 3M™ Imprint™ | 3M Deutschland GmbH | 4 |
| Henry Schein | Henry Schein, Inc. | 4 |
| 3M™ Impregum™ | 3M Deutschland GmbH | 3 |
| Imprint™ 4 Penta™ Putty | 3M Deutschland GmbH | 3 |
| 3M™ Penta™ | 3M Deutschland GmbH | 3 |
| Techno | DMG America LLC | 2 |
| Capsule Mixer CM-II | GC America Inc. | 2 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 2 |
| Biodentine Mixer | Septodont SAS Specialites Septodont | 2 |
| 3M™ Pentamix™ | 3M Deutschland GmbH | 2 |
| Silamat S6 | Ivoclar Vivadent Aktiengesellschaft | 1 |
Showing 12 of 48. All products under Amalgamator, Dental, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K910632 | 1991-03-15 |
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.