Data / Medical devices / South Korea / Mediclus Co., Ltd

Mediclus Co., Ltd: FDA-registered device maker in Cheongju-si Chungbuk, South Korea, 16 510(k) clearances

Name: Mediclus Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Mediclus Co., Ltd is registered with the FDA (registration 3013584861) in Cheongju-si Chungbuk, South Korea. It lists 17 device types. The FDA files 16 510(k) clearances under its listings, the newest dated August 21, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013584861
Address: No. 1210, 134 Gongdan-ro, Heungdeok-gu, Cheongju-si Chungbuk, South Korea, 28576
Owner or operator: Mediclus Co., Ltd (10053816)
Roles: Manufacturer
First device listed: January 13, 2017
Registered through: 2026
Brand names listed: Any-Cem, Any-Com, Any-Com Bulk, Any-Com Flow, Any-Com Kit, Any-Com Seal, Any-Com Universal Kit, Any-Core and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Manufacturer	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Manufacturer	accessdata.fda.gov
Carrier, Amalgam, Operative	EKI	1	Manufacturer	accessdata.fda.gov
Cement, Dental	EMA	2	Manufacturer	accessdata.fda.gov
Cord, Retraction	MVL	U	Manufacturer	accessdata.fda.gov
Dam, Rubber	EIE	1	Manufacturer	accessdata.fda.gov
Liner, Cavity, Calcium Hydroxide	EJK	2	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Manufacturer	accessdata.fda.gov
Powder, Porcelain	EIH	2	Manufacturer	accessdata.fda.gov
Preparer, Root Canal Endodontic	EKQ	1	Manufacturer	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Manufacturer	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Manufacturer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Manufacturer	accessdata.fda.gov
Varnish, Cavity	LBH	2	Manufacturer	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Manufacturer	accessdata.fda.gov
Zinc Oxide Eugenol	EMB	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 21, 2026	K262074	Any-Zircos	EIH	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
August 13, 2026	K254201	Any-Cem	EMA	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
July 21, 2026	K261728	One-Fil LC	EJK	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
May 14, 2026	K260485	Any-Etch	KLE	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
May 1, 2026	K260819	Any-Com Seal	EBC	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
February 27, 2026	K253797	One-Stop	MVL	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
January 12, 2026	K253167	Any-Paste	KIF	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
December 5, 2025	K252465	Any-Core	EBF	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
August 22, 2025	K251884	One-Fil Putty Injectable	KIF	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
June 6, 2025	K251283	Once-Fil Flow	EBF	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
April 14, 2025	K250823	Any-Com Flow	EBF	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
March 14, 2025	K243353	One-Fil Putty	KIF	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
February 7, 2025	K242713	Any-Com Bulk	EBF	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
September 26, 2024	K241147	Any-Com	EBF	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
January 26, 2024	K232182	One-Fil	KIF	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
May 22, 2023	K230465	Hi-Bond Universal	KLE	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 21, 2026. 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.