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

Ewoosoft Co., Ltd: FDA-registered device maker in Hwaseong-si Gyeonggi, South Korea, 32 510(k) clearances

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

Ewoosoft Co., Ltd is registered with the FDA (registration 3011189058) in Hwaseong-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 32 510(k) clearances under its listings, the newest dated May 23, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011189058
Address: 801-ho, Vatechnetworks Bldg. 13, Samsung 1-ro 2-gil, Hwaseong-si Gyeonggi, South Korea, 18449
Owner or operator: Ewoosoft Co., Ltd (10047111)
Roles: Manufacturer
First device listed: July 1, 2014
Registered through: 2026
Brand names listed: Clever One, E2, E3, EZ3D-I, EZDENTI-I, Ez3D Plus, Ez3D-i, Ez3D-i /E3 and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	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
May 23, 2025	K250005	Clever One	QIH	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
July 23, 2024	K241114	EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
July 14, 2023	K231757	Ez3D-i /E3	QIH	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
April 21, 2023	K230468	EzDent Web	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
February 17, 2023	K223820	EzDent-i / E2 / Prora View/ Smart M Viewer	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
September 6, 2022	K222069	Ez3D-i/E3	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
August 12, 2022	K222145	EzDent-i / E2 / Prora View/ Smart M Viewer	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
February 23, 2022	K220003	EzOrtho v1.3	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
October 4, 2021	K211795	EzDent-i/ E2/ Prora View/ Smart M Viewer	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
September 28, 2021	K211700	EzDent Web	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
August 23, 2021	K211793	EzOrtho	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
August 20, 2021	K211791	Ez3D-i/E3	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
October 22, 2020	K202948	EzOrtho	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
August 21, 2020	K202116	EzDent-i/ E2/ Prora View/ Smart M Viewer	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
March 13, 2020	K192888	EzOrtho	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
February 25, 2020	K200178	Ez3D-i /E3	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
January 20, 2020	K192098	EzMobile	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
April 19, 2019	K190791	Ez3D-i/E3	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
February 27, 2019	K190087	EzDent-i / E2 / Prora View	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
February 23, 2018	K173863	Ez3D-i /E3	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
October 26, 2017	K173094	OrthoVision	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
August 22, 2017	K172364	EzDent-i / E2 / Prora View	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
January 12, 2017	K163533	EzDent-i; E2; ProraView	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
December 23, 2016	K163539	Ez3D-i / E3	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
May 31, 2016	K161246	Ez3D-i / E3	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
May 13, 2016	K161117	EzDent-i / E2 / Prora View	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
January 3, 2016	K152746	Ez3D Plus	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
June 5, 2015	K150761	Ez3D-i/E3	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
April 2, 2015	K150747	EzDent-i /E2/Prora View	LLZ	Substantially Equivalent	LK Consulting Group USA, Inc.	accessdata.fda.gov
August 29, 2013	K131616	EZ3D-I, E3	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
August 29, 2013	K131594	EZDENTI-I; E2; PRORA VIEW	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov
August 15, 2013	K131570	ORTHOVISION	LLZ	Substantially Equivalent	Ewoosoft Co., Ltd.	accessdata.fda.gov

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Updated May 23, 2025. 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.