Data / Medical devices / File, Pulp Canal, Endodontic

File, Pulp Canal, Endodontic (EKS): 113 FDA-registered makers in 22 countries

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

113 establishments in 22 countries are registered with the FDA to make File, Pulp Canal, Endodontic (product code EKS, Class 1, 21 CFR 872.4565). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 31 510(k) clearances under this code, the latest on December 13, 2006, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this device Makers in China Watch this device

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

Makers by country

Country	Makers
China	50
United States	12
Germany	8
South Korea	7
India	5
Japan	4
Brazil	3
Pakistan	3
Canada	3
Taiwan	2
United Kingdom	2
France	2
Switzerland	2
Mexico	2
Sweden	1
Turkey	1
Russia	1
Italy	1
Israel	1
Vietnam	1
Poland	1
Spain	1

Makers of File, Pulp Canal, 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	Recall events	Source
3R Industria E Comercio Ltda	Sao Paulo, Brazil	Manufacturer	0	api.fda.gov
Angelus Industria De Productos Odontologicos	LONDRINA Parana, Brazil	Manufacturer	0	api.fda.gov
B&L Biotech Co., Inc	Ansan City Gyeonggi, South Korea	Manufacturer	0	api.fda.gov
B. Ali Impex	SIALKOT, Punjab, Pakistan	Manufacturer	0	api.fda.gov
Beijing C-Root Dental Medical Devices Co., Ltd.	Beijing, China	Manufacturer	0	api.fda.gov
Beijing Smart Technology Co., Ltd.	Beijing, China	Manufacturer	0	api.fda.gov
Beyes Dental Inc	Toronto Ontario, Canada	Manufacturer	0	api.fda.gov
BGSS Company Asia Limited	Zhabei Shanghai, China	Exporter to the US, Manufacturer	0	api.fda.gov
Brasseler U.S.A. Dental, LLC	Savannah, GA, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
BUSCH & CO. GmbH & Co. KG	ENGELSKIRCHEN North Rhine-Westphalia, Germany	Contract manufacturer, Manufacturer	0	api.fda.gov
BioMTA	Daejeon, South Korea	Manufacturer	0	api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.	Cangzhou Hebei, China	Exporter to the US, Manufacturer	0	api.fda.gov
Changzhou Sifary Medical Technology Co., Ltd.	Changzhou Jiangsu, China	Manufacturer	0	api.fda.gov
Chengdu Sani Medical Equipment Co.,ltd.	Chengdu Sichuan, China	Exporter to the US, Manufacturer	0	api.fda.gov
Coltene/Whaledent GMBH & Co. KG	LANGENAU Baden-Wurttemberg, Germany	Manufacturer	0	api.fda.gov
Coltene/Whaledent Inc.	Cuyahoga Falls, OH, United States	Manufacturer	0	api.fda.gov
Creative Endodontic Technology LLC	Ormond Beach, FL, United States	Specification developer	0	api.fda.gov
Changsha Easyinsmile Intelligence Technology Co.Ltd.	Changsha Hunan, China	Manufacturer	0	api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.	Shijiazhuang Hebei, China	Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler	0	api.fda.gov
Denjoy Dental Co., Ltd	Changsha city Hunan, China	Contract manufacturer, Manufacturer	0	api.fda.gov
Dentalmaster (xiamen) Medical Technology Co., Ltd.	Xiamen Fujian, China	Manufacturer	0	api.fda.gov
Deprag High Tech Materials ( Zhengzhou ) Co.,ltd.	ZHANGZHOU Henan, China	Manufacturer	0	api.fda.gov
Dhef Inc.	New Taipei City, Taiwan	Manufacturer	0	api.fda.gov
Diadent Group International	CHONGJU CITY Chungbuk, South Korea	Foreign private label distributor, Manufacturer	0	api.fda.gov
Directa AB	UPPLANDS VAESBY Stockholm, Sweden	Manufacturer	0	api.fda.gov
Dongguan Integrity Medical Instrument Co.,ltd.	Dongguan Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov
Easy Equipamentos Odontologicos Ltda	Belo Horizonte Minas Gerais, Brazil	Manufacturer	0	api.fda.gov
Endoperfection Ltd	Worcester Worcestershire, United Kingdom	Manufacturer	0	api.fda.gov
Epdent Co., Ltd.	Gimpo-city Gyeonggi, South Korea	Manufacturer	0	api.fda.gov
FFDM Tivoly	BOURGES CEDEX Centre-Val de Loire, France	Contract manufacturer	0	api.fda.gov
FKG Dentaire Sarl	LE CRET-DU-LOCLE Neuchatel, Switzerland	Manufacturer	0	api.fda.gov
Foshan Coxo Medical Instrument Co., Ltd.	Foshan Guangdong, China	Manufacturer	0	api.fda.gov
Foshan Oreck Medical Technology Co.,ltd	Foshan City Guangdong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Foshan Soco Precision Instrument Co.,ltd.	Foshan Guangdong, China	Manufacturer	0	api.fda.gov
Foshan CICADA Dental Instrument Co., Ltd.	Foshan Guangdong, China	Manufacturer	0	api.fda.gov
Garish Apparels	Wazirabad Punjab, Pakistan	Manufacturer	0	api.fda.gov
Gavin Biotechnology Co.,ltd	Jinzhong Shanxi, China	Exporter to the US, Manufacturer	0	api.fda.gov
Gebr. Brasseler GMBH & Co. KG	LEMGO North Rhine-Westphalia, Germany	Manufacturer, Specification developer	0	api.fda.gov
GNI Co., LTD	Hwaseong-si Gyeonggi, South Korea	Manufacturer	0	api.fda.gov
Guilin Kevin Peter Technology Co., Ltd.	Guilin Guangxi, China	Manufacturer	0	api.fda.gov
Hager & Meisinger GMBH	NEUSS North Rhine-Westphalia, Germany	Manufacturer	0	api.fda.gov
Hager & Werken GMBH	DUISBURG,DE-NOTA Hamburg, Germany	Manufacturer	0	api.fda.gov
Hangzhou Wise Medical Device Co.,ltd	Hangzhou Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov
Henan Baistra Medical Devices Limited	Zhengzhou Henan, China	Exporter to the US, Manufacturer	0	api.fda.gov
Hubei Guarddent Medical Technology Co.,ltd	Wuhan Hubei, China	Exporter to the US, Manufacturer	0	api.fda.gov
Huizhou Videya Technology Co., Ltd.	Huizhou Guangdong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Hansfive (Hangzhou) Dental Technology Co.,Ltd	Hangzhou city Zhejiang, China	Manufacturer	0	api.fda.gov
Henan Lusterdent Medical Instrument Co.,Ltd	Zhengzhou Henan, China	Manufacturer	0	api.fda.gov
Inci Dental Tibbi Malzeme Sanayi Ve Ticaret Limited Sirketi	Istanbul, Turkey	Manufacturer	0	api.fda.gov
Innovative Material & Devices, Inc.	Wuxi Jiangsu, China	Manufacturer	0	api.fda.gov
Industrias Apson S.A de C.V	AGUA PRIETA Sonora, Mexico	Contract manufacturer	0	api.fda.gov
Integra LifeSciences Production Corporation	Mansfield, MA, United States	Specification developer	0	api.fda.gov
J C India	Rajkot Gujarat, India	Manufacturer	0	api.fda.gov
Jining Orodeka Medical Equipment Co.,ltd	JiNing Shandong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Jinyuan Medical Equipment(tianjin)co.,ltd	Tianjin, China	Manufacturer	0	api.fda.gov
Jordco, Inc.	Hillsboro, OR, United States	Manufacturer	0	api.fda.gov
Kazan Medical Instruments Plant	Kazan Tatarstan, Russia	Manufacturer	0	api.fda.gov
Kerr Corporation	Pomona, CA, United States	Manufacturer	0	api.fda.gov
Kerr Italia, S.r.l.	SCAFATI Salerno, Italy	Manufacturer	0	api.fda.gov
Life Science Outsourcing, Inc.	Brea, CA, United States	Contract manufacturer, Contract sterilizer	0	api.fda.gov
Maillefer Instruments Holding Sarl	BALLAIGUES Vaud, Switzerland	Contract manufacturer, Manufacturer, Specification developer	0	api.fda.gov
Mani, Inc. (hanaoka Factory)	SHIOYA Tochigi, Japan	Contract manufacturer	0	api.fda.gov
Mani, Inc. (head Office)	UTSUNOMIYA Tochigi, Japan	Manufacturer	0	api.fda.gov
Mani, Inc. (takanezawa Facility)	SHIOYA Tochigi, Japan	Contract manufacturer	0	api.fda.gov
Maruchi	Wonju-si Gangwon, South Korea	Manufacturer	0	api.fda.gov
Medcave Private Limited	Sialkot Punjab, Pakistan	Manufacturer	0	api.fda.gov
Meta Biomed Co., Ltd.	Cheongju-si Chungbuk, South Korea	Manufacturer	0	api.fda.gov
Micro Diamond Technologies Ltd.- Medicnrg Ltd.	AFULA Northern, Israel	Manufacturer	0	api.fda.gov
Micron Corp.	OTA-KU Tokyo, Japan	Manufacturer	0	api.fda.gov
Mothers Medica Private Limited	Chennai Tamil Nadu, India	Manufacturer	0	api.fda.gov
Mani Hanoi Co. Ltd	Thai Nguyen Province, Vietnam	Contract manufacturer	0	api.fda.gov
Micro-Mega SA	BESANCON Doubs, France	Contract manufacturer, Manufacturer	0	api.fda.gov
Ningbo Denrotary Medical Apparatus Co., Ltd.	Ningbo City Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov
Onvet Medical Canada Inc	TORONTO Ontario, Canada	Manufacturer	0	api.fda.gov
Orikam Healthcare India Private Limited	Gurgaon Haryana, India	Manufacturer	0	api.fda.gov
Ormex S. de R.L. de C.V.	Yucatan Uman, Mexico	Contract manufacturer	0	api.fda.gov
Prevest Denpro Limited	Jammu Jammu and Kashmir, India	Manufacturer	0	api.fda.gov
Prima Dental Group	GLOUCESTER Gloucestershire, United Kingdom	Remanufacturer, Repackager or relabeler	0	api.fda.gov
Pulpdent Corporation	Watertown, MA, United States	Manufacturer	0	api.fda.gov
Reach Global India Pvt Ltd	Pune Maharashtra, India	Manufacturer	0	api.fda.gov
Shandong Hengfeng Kerui Medical Equipment Co., Ltd	Qingdao City Shandong, China	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov
Shanghai Dochem Industries Co., Ltd.	Shanghai, China	Manufacturer	0	api.fda.gov
Shanghai Xing Yu Medical Equipment Co., Ltd.	Shanghai, China	Manufacturer	0	api.fda.gov
Shanwei Perfect Medical Instruments Co.,ltd.	Shanwei Guangdong, China	Manufacturer	0	api.fda.gov
Shenzhen Denco Medical Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	0	api.fda.gov
Shenzhen Forever Medical Devices Co., Ltd	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	0	api.fda.gov
Shenzhen Perfect Medical Instruments Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0	api.fda.gov
Shenzhen Rogin Medical Co., Ltd	shenzhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov
Shenzhen Superline Technology Co.,ltd	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	0	api.fda.gov
Sino Ortho Limited	HANGZHOU Zhejiang, China	Contract manufacturer, Manufacturer	0	api.fda.gov
SKY DENT Corp for dental trading	New York, NY, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
SS White Burs LLC	Lakewood, NJ, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Suzhou Ramo Medical Instrument Co., Ltd.	Suzhou City Jiangsu, China	Exporter to the US, Manufacturer	0	api.fda.gov
Shanghai Toboom Dental Techonology CO., LTD.	Shanghai, China	Contract manufacturer, Contract sterilizer, Exporter to the US, Foreign private label distributor, Manufacturer	0	api.fda.gov
Smarter Alloys	Cambridge Ontario, Canada	Manufacturer	0	api.fda.gov
Suzhou Pac-Dent Technology Co., Ltd	SUZHOU CITY Jiangsu, China	Contract manufacturer	0	api.fda.gov
Symmetry Surgical GmbH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0	api.fda.gov
Tangshan Zhengtong Exhibition Co., Ltd.	Tangshan Hebei, China	Manufacturer	0	api.fda.gov
Tianjin Gapadent Co., Ltd.	Tianjin, China	Manufacturer	0	api.fda.gov
Tribest Dental Products Co Ltd	Yangzhong Jiangsu, China	Exporter to the US, Manufacturer	0	api.fda.gov
Tulsa Dental Products LLC	Johnson City, TN, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
United Dental Changzhou	Changzhou Jiangsu, China	Exporter to the US, Manufacturer	0	api.fda.gov
Univy Technology Advanced Co. Ltd	Shanghai, China	Exporter to the US, Manufacturer	0	api.fda.gov
US Endodontics, LLC	Johnson City, TN, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	1	api.fda.gov
VDW GMBH	MUNICH Bavaria, Germany	Manufacturer	0	api.fda.gov
Verdent Ltd.	LODZ Lodzkie, Poland	Manufacturer	0	api.fda.gov
Voco GMBH	CUXHAVEN Lower Saxony, Germany	Manufacturer	0	api.fda.gov
Wuhu Guli Ortho Co.,ltd	Wuhu Anhui, China	Contract manufacturer, Manufacturer	0	api.fda.gov
Zarc4endo	GIJON Asturias(Autonomous Community), Spain	Foreign private label distributor, Specification developer	0	api.fda.gov
Ze Fang Technology Co., Ltd.	Taichung, Taiwan	Manufacturer	0	api.fda.gov
Zhejiang Eksen Medical Technology Co., Ltd	Huzhou Zhejiang, China	Contract manufacturer, Manufacturer	0	api.fda.gov
ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, China	Manufacturer	0	api.fda.gov
Zhejiang Yahong Medical Apparatus Co., Ltd.	Huzhou Zhejiang, China	Exporter to the US, Manufacturer	0	api.fda.gov

Updated December 13, 2006. 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.