Data / Medical devices / Preparer, Root Canal Endodontic

Preparer, Root Canal Endodontic (EKQ): 34 FDA-registered makers in 10 countries

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

34 establishments in 10 countries are registered with the FDA to make Preparer, Root Canal Endodontic (product code EKQ, 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 2 510(k) clearances under this code, the latest on October 4, 1983, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

Country	Makers
United States	9
China	8
South Korea	7
Germany	3
Pakistan	2
India	1
Italy	1
Switzerland	1
Turkey	1
Mexico	1

Makers of Preparer, Root 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
Accompany Surgical	SIALKOT Punjab, Pakistan	Manufacturer	api.fda.gov
Aadi Med Private Limited	Dist. Palghar Maharashtra, India	Contract manufacturer, Manufacturer	api.fda.gov
B&L Biotech Co., Inc	Ansan City Gyeonggi, South Korea	Manufacturer	api.fda.gov
Beijing C-Root Dental Medical Devices Co., Ltd.	Beijing, China	Manufacturer	api.fda.gov
BUSCH & CO. GmbH & Co. KG	ENGELSKIRCHEN North Rhine-Westphalia, Germany	Contract manufacturer, Manufacturer	api.fda.gov
Changzhou Bomedent Medical Technology Co., Ltd	Changzhou Jiangsu, China	Manufacturer	api.fda.gov
Coltene/Whaledent Inc.	Cuyahoga Falls, OH, United States	Specification developer	api.fda.gov
Den Tag S.R.L.	MANIAGO, PN. Pordenone, Italy	Manufacturer	api.fda.gov
Denta Craft Instruments	Sialkot Punjab, Pakistan	Manufacturer	api.fda.gov
DENTSPLY DETREY GmbH	KONSTANZ Baden-Wurttemberg, Germany	Manufacturer	api.fda.gov
Dentsply LLC	York, PA, United States	Specification developer	api.fda.gov
Diadent Group International	CHONGJU CITY Chungbuk, South Korea	Manufacturer	api.fda.gov
Foshan Oreck Medical Technology Co.,ltd	Foshan City Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Guilin Kevin Peter Technology Co., Ltd.	Guilin Guangxi, China	Manufacturer	api.fda.gov
GUILIN YIKESHI Medical Device CO LTD	Guilin Guangxi, China	Manufacturer	api.fda.gov
Hantech Medical Device Co., Ltd.	Cixi Zhejiang, China	Contract manufacturer	api.fda.gov
Hdi Inc.	Seongnam-si Gyeonggi, South Korea	Manufacturer	api.fda.gov
Huizhou Videya Technology Co., Ltd.	Huizhou Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
I-Dent Innovations For Dentistry SA	Nyon Vaud, Switzerland	Contract manufacturer	api.fda.gov
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.	Konya, Turkey	Manufacturer	api.fda.gov
Inter-Med, Inc.	Racine, WI, United States	Manufacturer	api.fda.gov
Industrias Apson S.A de C.V	AGUA PRIETA Sonora, Mexico	Contract manufacturer	api.fda.gov
J & J Instruments, LLC	Northbrook, IL, United States	Specification developer	api.fda.gov
Medical Products Laboratories, Inc.	Philadelphia, PA, United States	Contract manufacturer	api.fda.gov
Mediclus Co., Ltd	Cheongju-si Chungbuk, South Korea	Manufacturer	api.fda.gov
Meta Biomed Co., Ltd.	Cheongju-si Chungbuk, South Korea	Manufacturer	api.fda.gov
Premier Dental Products Co.	Plymouth Meeting, PA, United States	Specification developer	api.fda.gov
Prime Dental Manufacturing, Inc.	Chicago, IL, United States	Manufacturer	api.fda.gov
Pulpdent Corporation	Watertown, MA, United States	Manufacturer, Repackager or relabeler	api.fda.gov
Shandong Hengfeng Kerui Medical Equipment Co., Ltd	Qingdao City Shandong, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Spident Co., Ltd.	INCHEON Gyeonggi, South Korea	Manufacturer	api.fda.gov
Symmetry Surgical GmbH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	api.fda.gov
Vericom Co., Ltd.	Chuncheon-Si Gangwon, South Korea	Manufacturer	api.fda.gov
Viarden Lab LLC	Mission, TX, United States	Manufacturer	api.fda.gov

Updated October 4, 1983. 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.