Data / Medical devices / Broach, Endodontic

Broach, Endodontic (EKW): 24 FDA-registered makers in 13 countries

Name: FDA-registered makers of Broach, Endodontic
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

24 establishments in 13 countries are registered with the FDA to make Broach, Endodontic (product code EKW, Class 1, 21 CFR 872.4565). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on June 24, 1987, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: EKW
Device class: 1
Regulation: 872.4565
Medical specialty: Dental

Makers by country

Country	Makers
China	8
Pakistan	2
United States	2
Japan	2
Germany	2
South Korea	1
Sweden	1
United Kingdom	1
Switzerland	1
Mexico	1
Russia	1
Vietnam	1
France	1

Makers of Broach, Endodontic

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	Source
B. Ali Impex	SIALKOT, Punjab, Pakistan	Manufacturer	api.fda.gov
Brasseler U.S.A. Dental, LLC	Savannah, GA, United States	Repackager or relabeler, Specification developer	api.fda.gov
CDM Center Of Excellence Ltd.	Beijing, China	Manufacturer	api.fda.gov
Diadent Group International	CHONGJU CITY Chungbuk, South Korea	Manufacturer	api.fda.gov
Directa AB	UPPLANDS VAESBY Stockholm, Sweden	Manufacturer	api.fda.gov
Dongguan Integrity Medical Instrument Co.,ltd.	Dongguan Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Endoperfection Ltd	Worcester Worcestershire, United Kingdom	Manufacturer	api.fda.gov
FKG Dentaire Sarl	LE CRET-DU-LOCLE Neuchatel, Switzerland	Manufacturer	api.fda.gov
Huizhou Videya Technology Co., Ltd.	Huizhou Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Henan Lusterdent Medical Instrument Co.,Ltd	Zhengzhou Henan, China	Manufacturer	api.fda.gov
Industrias Apson S.A de C.V	AGUA PRIETA Sonora, Mexico	Contract manufacturer	api.fda.gov
Kazan Medical Instruments Plant	Kazan Tatarstan, Russia	Manufacturer	api.fda.gov
Mani, Inc. (head Office)	UTSUNOMIYA Tochigi, Japan	Manufacturer	api.fda.gov
Mani, Inc. (takanezawa Facility)	SHIOYA Tochigi, Japan	Contract manufacturer	api.fda.gov
Mani Hanoi Co. Ltd	Thai Nguyen Province, Vietnam	Contract manufacturer	api.fda.gov
Micro-Mega SA	BESANCON Doubs, France	Manufacturer	api.fda.gov
Pomee Corporation	Sialkot Punjab, Pakistan	Manufacturer	api.fda.gov
Shenzhen Denco Medical Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	api.fda.gov
Shenzhen Rogin Medical Co., Ltd	shenzhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Shenzhen Superline Technology Co.,ltd	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
SKY DENT Corp for dental trading	New York, NY, United States	Manufacturer, Repackager or relabeler	api.fda.gov
Shanghai Toboom Dental Techonology CO., LTD.	Shanghai, China	Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer, Repackager or relabeler	api.fda.gov
Symmetry Surgical GmbH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	api.fda.gov
VDW GMBH	MUNICH Bavaria, Germany	Manufacturer	api.fda.gov

Updated June 24, 1987. 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.