Prosthetic devices · 21 CFR 872 Subpart D
Ac-Powered Dental Amalgamator
FDA device type “Amalgamator, Dental, Ac-Powered”.
- Companies listing it
- 2517 makers
- Brands and models
- 42
- 510(k) clearances
- 150 in five years
- FDA name
- Amalgamator, Dental, Ac-Powered
510(k) clearances per year, 1976–2026
Companies that list EFD
25 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Elite Mix · Hurrimix · Hurrimix 2 · Modulmix | 148 | 2026 |
| GC America Inc. | United States | Maker | Capsule Mixer CM-II · Sympress 120 | 137 | 2026 |
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | Amalgamator; DB338 | 6 | 2025 |
| Ivoclar Vivadent, AG | United States | Maker | Silamat S6 | 94 | 2026 |
| Sdi Limited | Australia | Maker | Capsule Mixer · Ultramat 2 · Ultramat S | 8 | 2022 |
| Lakong Medical Devices Co., Ltd. | China | Maker | D650N Digital Amalgamator | 2 | 2026 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | MixStar eMotion 115 V USA · MixStar-eMotion · MixStar-Tips 50x USA · MK Status Blue 25 ST USA | 4 | 2022 |
| Monitex Industrial Co., Ltd. | Taiwan | Maker | Henry Schein · SHOFU DENTAL CORPORATION | 9 | 2017 |
| DMG America, L.L.C. | United States | Maker | Amalgamator, Dental, AC-Powered - Zenith | 1 | 2013 |
| Solventum US LLC | United States | Maker | — | — | — |
| Huizhou Videya Technology Co., Ltd. | China | Maker | HL-AH (G5 / G6 / G8 / G10) | — | — |
| Renfert GmbH | Germany | Maker | DUOMIX · DUOMIX II · Dynamix Speed 2 · PROMIX one · +2 | — | — |
| Chung Song Industrial Co. | South Korea | Maker | SUNBURST | — | — |
| Enercon Technologies | United States | Maker | VIALMIX · VIALMIX®RFID | — | — |
| Lantheus Medical Imaging Inc | United States | Maker | VIALMIX · VIALMIX®RFID | — | — |
| E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd. | China | Maker | Dental Amalgamator; VOCO GIC Mixer | — | — |
| Motion Dental Equipment Corp. | Taiwan | Maker | — | — | — |
| Voco GmbH | Germany | Foreign exporter | VOCO Dynamic Dispenser · VOCO GIC Mixer · VOCO GIC Mixer II | 117 | 2026 |
| Sybron Dental Specialties | United States | Contract manufacturer | OPTIMIX · Volume Machine | 203 | 2026 |
| Kulzer, LLC | United States | Contract manufacturer | Dynamix Speed 2 | 37 | 2026 |
| Den-Mat Holdings, LLC | United States | Manufacturer | PowerMix Automatic Impression Material Dispenser | 8 | 2026 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Manufacturer | DENTAL AMALGAMATOR | 5 | 2022 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC D650N Digital Amalgamator | 3 | 2007 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | STAR5 | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 26 Jul 1999 | K991913 | PENTAMIX 2 | Espe Dental AG |
| 6 Oct 1992 | K923974 | SILIMAT PLUS | Ivoclar North America, Inc. |
| 3 Jun 1992 | K922203 | IPT CAPSULE MIXER | Ipt Technologies, Inc. |
| 2 Mar 1992 | K915847 | AUTOMIX DENTAL AMALGAMATOR | Kerr Corporation (Danbury) |
| 13 Nov 1991 | K914341 | MIXOMAT AMALGAMATOR | Degussa AG |
| 13 Nov 1991 | K914340 | DUOMAT 3 AMALGAMATOR | Degussa AG |
| 7 Nov 1991 | K914339 | DENTOMAT 3 AMALGAMATORS | Degussa AG |
| 15 Mar 1991 | K910632 | ACCU-MIX AMALGAMATOR | Wykle Research, Inc. |
| 22 Jun 1990 | K901909 | SILAMAT (AMALGAMATOR) | Ivoclar North America, Inc. |
| 12 Jun 1989 | K891612 | DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. | Implant Innovations International, Inc. |
| 30 May 1989 | K891064 | ESPE CAPMIX | Espe GmbH (Us) |
| 11 May 1988 | K880993 | AMALGAMATOR | Acecodent, Inc. |
| 19 Sep 1979 | K791410 | AMALGAMATOR MODEL SDC-- | Sierra Laboratories, Inc. |
| 21 Apr 1978 | K780560 | DENTAL AMALGAMATOR | L.D. Caulk Co. |
| 20 Oct 1977 | K771901 | CAPMIX | Espe Dental Products |
Official records: FDA product classification for EFD · 21 CFR 872.3100.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026