FDA.reportPublic FDA data

bright CT

Primary DI
08809772430594
Brand
bright CT
Company
Dentium Co., Ltd
Model
ICT-R02-2TC
Device description
This product is a dental computed tomography device designed to obtain images of the patient's teeth, nasal cavity, and jaw joint by placing X-rays and image detection sensors facing each other to obtain images while rotating around the patient's central axis, and to analyze while displaying tomography images of the patient's interest on the screen through computer calculation. In addition, this product includes functions such as reconstructing images and displaying images, modifying images, and storing images as an image manipulation function.It is equipped with a CT (Computational tomography) mode that can acquire a three-dimensional tomography image and a Panoramic mode for acquiring a two-dimensional semi-elliptical flat image, and includes a Cephalo mode used for rear and lateral head photography with a Scan method as an optional specification.
Published
2023-12-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OASX-Ray, Tomography, Computed, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OASX-Ray, Tomography, Computed, DentalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231181000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231181000bright CTDentium Co., Ltd (Ict Branch)2023-12-14OAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809772430594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809772430594088097724305948809772430594

GMDN Terms#

Term, Definition table
TermDefinition
Stationary panoramic/tomographic dental x-ray system, digitalA diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures. It uses digital techniques for image capture, manipulation and display and may include various image processing and analysis capabilities. This system is designed with the capability to produce two or more special purpose dental x-ray examinations: linear scanning, panoramic, cephalometric, linear tomography, spiral tomography, scanograms.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+827070989124shlim1@dentium.com

Regulatory Flags#

DUNS number
695504638
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809772430563bright CTICT-R02-1T2023-12-26
08809772430570bright CTICT-R02-1TC2023-12-26
08809772430587bright CTICT-R02-2T2023-12-26
08809772430600bright CTICT-R02-2TS2023-12-26
08809772430617bright CTICT-R02-2TSC2023-12-26
08809460309836bright MCTICT-R01-M2021-04-22
08809544906340rainbow CTICT-R012021-04-22
08809544906357rainbow CTICT-R01-L2021-04-22
08809460309843iCTmotorWL-1WL-12020-09-11
08809460309850Intra Oral SensorIOX1IOX12020-08-06
08809460309867Intra Oral SensorIOX2IOX22020-08-06

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Primary DI, Brand, Company table
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06975066322103MeyerHefei Meyer Optoelectronic Technology Inc.OAS2026-09-30
00854810007168CLARISIcRco, Inc.OAS2026-07-22
08800016401936Green X 12 SEVATECH CO., LTD.OAS2026-06-01
08800016401943Green X 12 SEVATECH CO., LTD.OAS2026-06-01
60192155951237CS 9600CARESTREAM DENTAL LLCOAS2026-05-15
60192155951244CS 9600CARESTREAM DENTAL LLCOAS2026-05-15
E27668234830Primevision 3DSIRONA Dental Systems GmbHOAS2026-04-30
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