Data / Medical devices / South Korea / HDX Will Corp.

HDX Will Corp.: FDA-registered device maker in Heungdeok-gu, Cheongju-si, Chungcheongbuk-do Chungbuk, South Korea, 10 510(k) clearances

Name: HDX Will Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

HDX Will Corp. is registered with the FDA (registration 3013511605) in Heungdeok-gu, Cheongju-si, Chungcheongbuk-do Chungbuk, South Korea. It lists 6 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 30, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013511605
Address: #105,106,201,202,203,204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do Chungbuk, South Korea, 28161
Owner or operator: HDX WILL CORP. (10053323)
Roles: Exporter to the US, Manufacturer
First device listed: November 21, 2016
Registered through: 2026
Brand names listed: DENTIOIII series (DENTIOIII, DENTIOIII-S), DENTRA III, DENTRI Max (DENTRI?, DENTRI-C?, DENTRI-S?), DENTRI? series (DENTRI?, DENTRI-C?, DENTRI-S?), DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa), Dental X-ray system, Real Arch, Star-X; Intraoral X-ray System and more

Devices it lists

Device	Product code	Class	Role	Source
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Intraoral	EAP	2	Exporter to the US	accessdata.fda.gov
X-Ray, Tomography, Computed, Dental	OAS	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
December 30, 2021	K211159	eco-x Series (eco-x, eco-x-s)	OAS	Substantially Equivalent	Hdx Will Corp.	accessdata.fda.gov
December 15, 2021	K211114	Will3D	LLZ	Substantially Equivalent	Hdx Will Corp.	accessdata.fda.gov
October 19, 2021	K212254	DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)	OAS	Substantially Equivalent	Hdx Will Corp.	accessdata.fda.gov
December 27, 2019	K192700	Xcam	EHD	Substantially Equivalent	Hdx Will Corp.	accessdata.fda.gov
March 15, 2019	K190357	Star-X, Intraoral X-ray System	EHD	Substantially Equivalent	Hdx Will Corp.	accessdata.fda.gov
November 21, 2018	K181297	DENTIOIII series (DENTIOIII, DENTIOIII-S)	MUH	Substantially Equivalent	Hdx Will Corp.	accessdata.fda.gov
March 21, 2018	K172168	WillCeph	LLZ	Substantially Equivalent	Hdx Will Corp.	accessdata.fda.gov
May 8, 2017	K170180	Will3D	LLZ	Substantially Equivalent	Hdx Will Corp.	accessdata.fda.gov
September 30, 2016	K160140	DENTRIa series	OAS	Substantially Equivalent	Hdx Will Corp.	accessdata.fda.gov
April 19, 1995	K950532	TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY	EAP	Substantially Equivalent	Trophy Radiologie	accessdata.fda.gov

Compare with other makers

Updated December 30, 2021. 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.