Data / Medical devices / Reamer, Pulp Canal, Endodontic

Reamer, Pulp Canal, Endodontic (EKP): 38 FDA-registered makers in 13 countries

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

38 establishments in 13 countries are registered with the FDA to make Reamer, Pulp Canal, Endodontic (product code EKP, 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 6 510(k) clearances under this code, the latest on December 28, 1982, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

Country	Makers
United States	8
China	8
Germany	7
Switzerland	3
France	2
Mexico	2
Japan	2
Sweden	1
United Kingdom	1
Pakistan	1
Russia	1
Italy	1
Vietnam	1

Makers of Reamer, 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	Source
Abrasive Technology, LLC	Lewis Center, OH, United States	Manufacturer	api.fda.gov
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Manufacturer	api.fda.gov
Anqing Clean Dental Instrument Technology Co.,ltd	Anqing City Anhui, China	Exporter to the US, Manufacturer	api.fda.gov
BGSS Company Asia Limited	Zhabei Shanghai, China	Exporter to the US, Manufacturer	api.fda.gov
BUSCH & CO. GmbH & Co. KG	ENGELSKIRCHEN North Rhine-Westphalia, Germany	Contract manufacturer, Manufacturer	api.fda.gov
Dentsply LLC	Milford, DE, United States	Manufacturer	api.fda.gov
Directa AB	UPPLANDS VAESBY Stockholm, Sweden	Manufacturer	api.fda.gov
Dongguan Wanjin Industrial Co., Ltd	DongGuang Guangdong, China	Remanufacturer	api.fda.gov
Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, Germany	Manufacturer	api.fda.gov
Endoperfection Ltd	Worcester Worcestershire, United Kingdom	Manufacturer	api.fda.gov
Essential Dental Systems, Inc.	S Hackensack, NJ, United States	Repackager or relabeler, Specification developer	api.fda.gov
FFDM Tivoly	BOURGES CEDEX Centre-Val de Loire, France	Contract manufacturer	api.fda.gov
FKG Dentaire Sarl	LE CRET-DU-LOCLE Neuchatel, Switzerland	Manufacturer	api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	api.fda.gov
Gebr. Brasseler GMBH & Co. KG	LEMGO North Rhine-Westphalia, Germany	Contract manufacturer, Manufacturer	api.fda.gov
Harald Nordin S.A.	Montreux Vaud, Switzerland	Manufacturer	api.fda.gov
Holmed LLC	Attleboro, MA, United States	Contract manufacturer, Manufacturer	api.fda.gov
Innovative Material & Devices, Inc.	Wuxi Jiangsu, China	Manufacturer	api.fda.gov
Industrias Apson S.A de C.V	AGUA PRIETA Sonora, Mexico	Contract manufacturer	api.fda.gov
Integra LifeSciences Production Corporation	Mansfield, MA, United States	Manufacturer	api.fda.gov
Jinyuan Medical Equipment(tianjin)co.,ltd	Tianjin, China	Manufacturer	api.fda.gov
Kazan Medical Instruments Plant	Kazan Tatarstan, Russia	Manufacturer	api.fda.gov
Kerr Corporation	Orange, CA, United States	Manufacturer	api.fda.gov
Kerr Corporation	Pomona, CA, United States	Manufacturer	api.fda.gov
Kerr Italia, S.r.l.	SCAFATI Salerno, Italy	Specification developer	api.fda.gov
Maillefer Instruments Holding Sarl	BALLAIGUES Vaud, Switzerland	Contract manufacturer, 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
Ormex S. de R.L. de C.V.	Yucatan Uman, Mexico	Contract manufacturer	api.fda.gov
Shenzhen Denco Medical Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, 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, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler	api.fda.gov
Symmetry Surgical GmbH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	api.fda.gov
Ustomed Instrumente GMBH & Co. KG	Tuttlingen Baden-Wurttemberg, Germany	Manufacturer	api.fda.gov
VDW GMBH	MUNICH Bavaria, Germany	Manufacturer, Repackager or relabeler	api.fda.gov

Updated December 28, 1982. 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.