Dentsply Sirona Mixer
Dentspy Sirona Mixer
4manufacturers in China registered for this device type
1catalogue number
1recall
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 | SDI Ltd., Australia |
|---|---|
| FDA product code | EFD |
| Device type | Amalgamator, Dental, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3100 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-07-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2026-07-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5546068 | Withdrawn |
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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-07-20 | Class II | Device Design | Potential for electrical discharge from unit when unplugged. | 1,444 units |
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.