bright CT

GUDID 08809772430617

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.

Dentium Co., Ltd

Stationary panoramic/tomographic dental x-ray system, digital
Primary Device ID08809772430617
NIH Device Record Key10b0e529-465b-42f5-865d-f2b1fc6e7fb2
Commercial Distribution StatusIn Commercial Distribution
Brand Namebright CT
Version Model NumberICT-R02-2TSC
Company DUNS695504638
Company NameDentium Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+827070989124
Emailshlim1@dentium.com
Phone+827070989124
Emailshlim1@dentium.com
Phone+827070989124
Emailshlim1@dentium.com
Phone+827070989124
Emailshlim1@dentium.com
Phone+827070989124
Emailshlim1@dentium.com
Phone+827070989124
Emailshlim1@dentium.com
Phone+827070989124
Emailshlim1@dentium.com
Phone+827070989124
Emailshlim1@dentium.com
Phone+827070989124
Emailshlim1@dentium.com
Phone+827070989124
Emailshlim1@dentium.com
Phone+827070989124
Emailshlim1@dentium.com
Phone+827070989124
Emailshlim1@dentium.com
Phone+827070989124
Emailshlim1@dentium.com
Phone+827070989124
Emailshlim1@dentium.com
Phone+827070989124
Emailshlim1@dentium.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809772430617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OASX-Ray, Tomography, Computed, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-03
Device Publish Date2023-12-26

On-Brand Devices [bright CT]

08809772430617This product is a dental computed tomography device designed to obtain images of the patient's t
08809772430600This product is a dental computed tomography device designed to obtain images of the patient's t
08809772430594This product is a dental computed tomography device designed to obtain images of the patient's t
08809772430587ICT-R02-2T
08809772430570This product is a dental computed tomography device designed to obtain images of the patient's t
08809772430563This product is a dental computed tomography device designed to obtain images of the patient's t

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