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 ID: 08809772430617
• NIH Device Record Key: 10b0e529-465b-42f5-865d-f2b1fc6e7fb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bright CT
• Version Model Number: ICT-R02-2TSC
• Company DUNS: 695504638
• Company Name: Dentium Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +827070989124
• Email: shlim1@dentium.com
• Phone: +827070989124
• Email: shlim1@dentium.com
• Phone: +827070989124
• Email: shlim1@dentium.com
• Phone: +827070989124
• Email: shlim1@dentium.com
• Phone: +827070989124
• Email: shlim1@dentium.com
• Phone: +827070989124
• Email: shlim1@dentium.com
• Phone: +827070989124
• Email: shlim1@dentium.com
• Phone: +827070989124
• Email: shlim1@dentium.com
• Phone: +827070989124
• Email: shlim1@dentium.com
• Phone: +827070989124
• Email: shlim1@dentium.com
• Phone: +827070989124
• Email: shlim1@dentium.com
• Phone: +827070989124
• Email: shlim1@dentium.com
• Phone: +827070989124
• Email: shlim1@dentium.com
• Phone: +827070989124
• Email: shlim1@dentium.com
• Phone: +827070989124
• Email: shlim1@dentium.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809772430617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231181

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-03
• Device Publish Date: 2023-12-26

On-Brand Devices [bright CT]

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