Amalgamator, Dental, Ac-Powered

FDA product code EFD · Class I (low risk) · 21 CFR 872.3100 · Dental

15510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K991913Pentamix 2EFD · Traditional Espe Dental AG07/26/1999SE
K923974Silimat PlusEFD · Traditional Ivoclar North America, Inc.10/06/1992SE
K922203Ipt Capsule MixerEFD · Traditional Ipt Technologies, Inc.06/03/1992SE
K915847Automix Dental AmalgamatorEFD · Traditional Kerr Corporation (Danbury)03/02/1992SE
K914341Mixomat AmalgamatorEFD · Traditional Degussa AG11/13/1991SE
K914340Duomat 3 AmalgamatorEFD · Traditional Degussa AG11/13/1991SE
K914339Dentomat 3 AmalgamatorsEFD · Traditional Degussa AG11/07/1991SE
K910632Accu-Mix AmalgamatorEFD · Traditional Wykle Research, Inc.03/15/1991SE
K901909Silamat (Amalgamator)EFD · Traditional Ivoclar North America, Inc.06/22/1990SE
K891612Drilling Machine W/Handpieces & Internal Irriga.EFD · Traditional Implant Innovations International, Inc.06/12/1989SE
K891064Espe CapmixEFD · Traditional Espe GmbH (Us)05/30/1989SE
K880993AmalgamatorEFD · Traditional Acecodent, Inc.05/11/1988SE
K791410Amalgamator Model Sdc--EFD · Traditional Sierra Laboratories, Inc.09/19/1979SE
K780560Dental AmalgamatorEFD · Traditional L.D. Caulk Co.04/21/1978SE
K771901CapmixEFD · Traditional Espe Dental Products10/20/1977SE

Recalls

RecallProductFirmInitiated
Z-2954-2026 Class IIDentsply Sirona Capsule Mixer Model No. 5546068Potential for electrical discharge from unit when unplugged. SDI Limited07/20/2026Open, Classified