bright CT

GUDID 08809772430587

Dentium Co., Ltd

Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 08809772430587
• NIH Device Record Key: 6687d377-9f27-499d-a6e3-b347420b6387
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bright CT
• Version Model Number: ICT-R02-2T
• 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	08809772430587 [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