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Dentium Co., Ltd (Ict Branch)

Korea, Republic · Yongin Gyeonggi

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, Singapore, Russia — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 9 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

7valid device licences

Class I 2Class II 5

SGSingaporeHSA SMDR

3device registrations

CLASS B 2CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

3active registrations

Class 2a 2Class 2b 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States9 registration records, 4 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: DENTIUM CO.,LTD(ICT BRANCH)

FDA 510(k) clearances by year

12020 · K201247

22021 · K200271

12023 · K231181

FDA listed device types

System, X-Ray, Extraoral Source, Digital 1X-Ray, Tomography, Computed, Dental 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1Controller, Foot, Handpiece And Cord 1

Market	Identifier	Name	Class / date
US	K231181	bright CT	2023-12-14
US	K200271	rainbow CT	2021-04-16
US	K200270	rainbow MCT	2021-04-16

Dentium Co., Ltd (Ict Branch)

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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