Home › Device types › EFD
Amalgamator, Dental, Ac-Powered
FDA product code EFD · Class 1 · Dental
89
Registered devices
6
Adverse events
1
Recalls
15
510(k) clearances
Devices with this code
RotoMix™ — 3M Deutschland GmbHDUOMIX II — Renfert GmbHCresent® Wig-L-Bug — DENTSPLY INTERNATIONAL INC.Impregum™ Penta™ Soft Heavy Body — 3M Deutschland GmbHImprint™ 4 Penta™ Super Quick Heavy — 3M Deutschland GmbH3M™ Impregum™ — 3M Deutschland GmbHLinea Tac 2000 Manual Amalgamator — Wykle Research, Inc3M™ Penta™ — 3M Deutschland GmbH3M™ Pentamix™ — 3M Deutschland GmbHULTRAMAT S — SDI LIMITEDDentsply Sirona Mixer — SDI LIMITEDPowerMix™ Automatic Impression Material Dispenser — DEN-MAT HOLDINGS, LLCImprint™ 4 Penta™ Putty — 3M Deutschland GmbH3M™ Impregum™ — 3M Deutschland GmbHCresent® Wig-L-Bug — DENTSPLY INTERNATIONAL INC.3M™ Imprint™ — 3M Deutschland GmbH3M™ Penta™ — 3M Deutschland GmbHHenry Schein — HENRY SCHEIN, INC.EON — BENCO DENTAL SUPPLY CO.Henry Schein Maxima — HENRY SCHEIN, INC.Impregum™ Penta™ — 3M Deutschland GmbHOSSTEM IMPLANT CO., LTD. CHAIR BUSINESS — Osstem Implant Co.,Ltd.Linea Tac 400M Amalgamator — Wykle Research, Inc3M™ Imprint™ — 3M Deutschland GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-20 | SDI Limited | Potential for electrical discharge from unit when unplugged. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.