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

Ray Co., Ltd: FDA-registered device maker in Yongin-si Gyeonggi, South Korea, 17 510(k) clearances

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

Ray Co., Ltd is registered with the FDA (registration 3010445368) in Yongin-si Gyeonggi, South Korea. It lists 10 device types. The FDA files 17 510(k) clearances under its listings, the newest dated April 9, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Ray Co., Ltd

FDA registration number: 3010445368
Address: 1F~3F, 4F(Part), 5F, 265, Daeji-ro, Yongin-si Gyeonggi, South Korea, 16882
Owner or operator: Ray Co., Ltd (10045096)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: April 24, 2015
Registered through: 2026
Brand names listed: OnDemand3DTM, R2 Studio Q, RAYDENT C&B, RAYDENT DM, RAYDENT SG, RAYDENT SW, RAYDent Designer, RAYPreMiere and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Orthodontic Software	PNN	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Exporter to the US, Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Exporter to the US, Manufacturer	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Manufacturer	accessdata.fda.gov
Teeth, Artificial, Posterior With Metal Insert	ELJ	1	Manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Intraoral	EAP	2	Exporter to the US	accessdata.fda.gov
X-Ray, Tomography, Computed, Dental	OAS	2	Contract manufacturer, 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
April 9, 2026	K260462	RCT800	OAS	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
November 25, 2025	K251798	RCT700	OAS	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
May 21, 2025	K251109	SMARTDent	LLZ	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
March 12, 2025	K243903	RCT600	OAS	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
May 16, 2024	K233625	RAYDENT SW	PNN	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
April 18, 2024	K232325	RAYSCAN a-Expert	MUH	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
August 31, 2023	K232287	RAYSCAN a-Expert3D	OAS	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
April 11, 2023	K230753	RCT800	OAS	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
November 29, 2021	K213226	RCT700	OAS	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
October 22, 2019	K192737	RCT800	OAS	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
April 24, 2019	K190812	RAYSCAN a-Expert3D	OAS	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
December 14, 2018	K182805	RCT800	OAS	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
October 16, 2018	K182614	RCT700	OAS	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
April 15, 2016	K160788	RIOScan (RPS500)	MUH	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
April 22, 2015	K142058	RAYSCAN A-EXPERT	MUH	Substantially Equivalent	Ray Co., Ltd.	accessdata.fda.gov
March 16, 2007	K070464	ONDEMAND3D	LLZ	Substantially Equivalent	Cybermed, Inc.	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 April 9, 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.