Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017403245

FEI Number

3017403245

Entity Name

DENTIUM CO.,LTD(ICT BRANCH)

City/State/Country

Suwon Gyeonggi, KR

Establishment Address

(16229) 76, Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon Gyeonggi 16229, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dentium Co.,Ltd(ICT branch) (Owner Number: 10076095)

Owner / Operator Contact Address

(16229) 76, Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon, KR-41 16229, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201247

PMA Number

N/A

All Registered Proprietary Names

rainbow CT bright CT bright MCT rainbow MCT IOX2 IOX1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2021-04-19
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2023-12-19
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2021-04-19
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2020-07-07
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2020-07-07

Official Correspondent

Hyojeong Lee

US Agent Details

EUNKYUNG SON Email: json@dentiumusa.com Phone: (714) 2260229

Related Public Records

Same Entity

Dentium Co.,Ltd(ICT branch)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3031093388	DENTIUM CO.,LTD(ICT BRANCH)	Yongin Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.

Similar Registrations

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9615832	OWANDY RADIOLOGY	CROISSY-BEAUBOURG Seine-et-Marne, FR
3004706313	VATECH CO., LTD.	Hwaseong-si Gyeonggi, KR
3005383085	PALODEX GROUP OY	Tuusula Uusimaa, FI
3005843418	GENORAY CO., LTD.	Seongnam-si Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017403245. Last updated year: 2026. Please use registration number 3017403245 when referencing this establishment in official correspondence.