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Dentium Co., Ltd. (ICT Branch)

South Korea KR-MF-000034082 Last updated 25 Oct 2026

Devices
12
Registries
EUDAMEDGUDIDFDA 510(k)FDA
FDA recalls
0

Catalogue12

  • bright CT Ref ICT-R02-2TS

    Class IIb EUDAMEDFDA UDI Active

  • rainbow MCT Ref K200270

    Class II FDA 510(k) Active

  • Intraoral Sensor Ref K201247

    Class II FDA 510(k) Active

  • rainbow CT Ref K200271

    Class II EUDAMEDFDA 510(k)FDA UDI Active

  • bright CT Ref ICT-R02-2TC

    Class IIb EUDAMEDFDA UDI Active

  • bright CT Ref ICT-R02-2TSC

    Class IIb EUDAMEDFDA UDI Active

  • bright CT Ref ICT-R02-1TC

    Class IIb EUDAMEDFDA UDI Active

  • bright Alone Ref ICT-CH02

    Class IIa EUDAMED Active

  • bright CT Ref ICT-R02-2T

    Class IIb EUDAMEDFDA UDI Active

  • bright CT Ref ICT-R02-1T

    Class IIb EUDAMEDFDA UDI Active

  • iCTmotor Ref WL-1

    Class IIa EUDAMEDFDA UDI Active

  • iCTmotor Ref WH-1

    Class IIa EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

DNV Product Assurance AS 2460 1 certificate

  • C651018 Issued

    Quality management system EU MDR

    Issued
    24 Oct 2025
    Expires
    23 Oct 2030

Related companies

Authorised representatives

Notified bodies

What Dentium Co., Ltd. (ICT Branch) makes

Dentium Co., Ltd. (ICT Branch) manufactures dental imaging devices including cone beam computed tomography (CBCT) scanners such as bright CT, rainbow CT, and iCTmotor, as well as intraoral sensors.

The company's products are classified as Class II, Class IIa, and Class IIb medical devices and are listed in the EU's EUDAMED and FDA's 510(k) registries. Dentium Co., Ltd. (ICT Branch) is based in South Korea.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Dentium Co., Ltd. (ICT Branch) manufacture?

Dentium Co., Ltd. (ICT Branch) manufactures dental imaging devices including cone beam computed tomography (CBCT) scanners such as bright CT, rainbow CT, and iCTmotor, as well as intraoral sensors.

Where is Dentium Co., Ltd. (ICT Branch) based?

Dentium Co., Ltd. (ICT Branch) is based in South Korea, as indicated by the country code KR in the device data.

Which regulatory registries list Dentium Co., Ltd. (ICT Branch) devices?

The company's devices are listed in the EU's EUDAMED registry and the FDA's 510(k) registry, as specified in the device data.

How are Dentium Co., Ltd. (ICT Branch) devices classified?

The company's products are classified as Class II, Class IIa, and Class IIb medical devices, which indicates varying levels of risk and regulatory control requirements.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
South Korea(from SRN)
Address
76, Changnyong-daero 256beon-gil, Suwon-si, Gyeonggi-do, South Korea
Website
dentium.com
Phone
+82 70 7098 9124
PRRC contact
Ba da Lee
EUDAMED SRN
KR-MF-000034082
FDA FEI number
3017403245