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bright CT

by Dentium Co., Ltd. (ICT Branch) South Korea EUDAMED510(k)GUDID

Ref ICT-R02-1TModel ICT-R02-1T, ICT-R02-1TC, ICT-R02-2T, ICT-R02-2TC, ICT-R02-2TS, ICT-R02-2TSC Product code OASEMDN Z1103030102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880954490Dental_X-ray4K Basic UDI-DIDate7 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809772430563 UDI-DIDate26 Dec 2023ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK231181 Date14 Dec 2023IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Generic Name
Stationary panoramic/tomographic dental x-ray system, digital
Model / Reference
ICT-R02-1T, ICT-R02-1TC, ICT-R02-2T, ICT-R02-2TC, ICT-R02-2TS, ICT-R02-2TSC
Primary DI / UDI-DI
08809772430563
Basic UDI-DI
880954490Dental_X-ray4K
510(k) Number
FDA Product Code
OAS
EMDN Code
Z1103030102 Equipment for extraoral dental radiology, digital
GMDN Term
Stationary panoramic/tomographic dental x-ray system, digital
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1750
Market of Registration
Hungary
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000034082
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Dentium Co., Ltd. (ICT Branch)

  • bright CT

    Class IIb

  • rainbow MCT

    Class II

  • Intraoral Sensor

    Class II

  • rainbow CT

    Class II

  • bright Alone

    Class IIa

  • iCTmotor

    Class IIa

See all devices from Dentium Co., Ltd. (ICT Branch) →

Properties & raw data

Show properties, registry sources and raw records
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No

Sources (3)

  • EUDAMED cc247b11-9f2e-4360-937c-d7b22de22baa 61 fields · synced 24 Oct 2026
  • FDA UDI 50f032af-762a-4bb2-834c-2433b9a79f6f 35 fields · synced 30 May 2026
  • FDA 510(k) K231181 1 fields · synced 18 May 2026