Data / Medical devices / Amalgamator, Dental, Ac-Powered

Amalgamator, Dental, Ac-Powered (EFD): 18 FDA-registered makers in 9 countries

Name: FDA-registered makers of Amalgamator, Dental, Ac-Powered
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

18 establishments in 9 countries are registered with the FDA to make Amalgamator, Dental, Ac-Powered (product code EFD, Class 1, 21 CFR 872.3100). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on July 26, 1999, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code: EFD
Device class: 1
Regulation: 872.3100
Medical specialty: Dental

Makers by country

Country	Makers
United States	4
China	4
Germany	3
Taiwan	2
South Korea	1
Japan	1
Liechtenstein	1
Austria	1
Australia	1

Makers of Amalgamator, Dental, Ac-Powered

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Solventum Germany GmbH	SEEFELD Bavaria, Germany	Manufacturer	1	July 26, 1999	0	api.fda.gov
Chung Song Industrial Co.	YONGIN-SI Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Dentsply LLC	York, PA, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
DMG America LLC	Englewood, NJ, United States	Manufacturer	0		0	api.fda.gov
DMG Chemisch Pharmazeutische Fabrik GMBH	Hamburg, Germany	Manufacturer	0		0	api.fda.gov
E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd.	Hangzhou Zhejiang, China	Manufacturer	0		0	api.fda.gov
Enercon Technologies	Gray, ME, United States	Contract manufacturer	0		0	api.fda.gov
Foshan Coxo Medical Instrument Co., Ltd.	Foshan Guangdong, China	Manufacturer	0		0	api.fda.gov
GC Corp.	ITABASHI-KU Tokyo, Japan	Manufacturer	0		0	api.fda.gov
Huizhou Videya Technology Co., Ltd.	Huizhou Guangdong, China	Manufacturer	0		0	api.fda.gov
Ivoclar Vivadent AG	Schaan, Liechtenstein	Specification developer	0		0	api.fda.gov
IVOCLAR VIVADENT Manufacturing GmbH	BURS Vorarlberg, Austria	Contract manufacturer	0		0	api.fda.gov
Lakong Medical Devices Co., Ltd.	Dongguan Guangdong, China	Manufacturer	0		0	api.fda.gov
LANTHEUS MEDICAL IMAGING, Inc.	N Billerica, MA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Monitex Industrial Co., Ltd.	SAN-CHUNG CITY Taipei, Taiwan	Contract manufacturer	0		0	api.fda.gov
Motion Dental Equipment Corporation	New Taipei City, Taiwan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Renfert GMBH	HILZINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Sdi Ltd.	BAYSWATER Victoria, Australia	Manufacturer	0		1	api.fda.gov

Updated July 26, 1999. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.