T2 Plus

GUDID 08800000996059

T2 PLUS is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray supporter, image processing unit (sensor), PC, and software. The apparatus attached to the equipment column is a structure that can be rotated 360 degree by the system control unit. This system control unit actuates the motor control, X-ray generator, and image processing unit (sensor). The height controlling unit controls the column and adjusts the height of the equipment. The X-ray generator and image processing unit (sensor) are attached to the rotating apparatus. When the rotating apparatus starts the rotation, X-ray is irradiated from the X-ray generator (generating unit). This X-ray irradiation penetrates the subject and reaches the image processing unit (sensor), and then is converted into electric signals to secure imagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software.

Osstem Implant Co.,Ltd.

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 08800000996059
• NIH Device Record Key: 53ef9d41-4652-44de-b0b0-4d3348e5ad14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2 Plus
• Version Model Number: T2-C-P
• Company DUNS: 694893867
• Company Name: Osstem Implant 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com
• Phone: +1 (201) 266 0657
• Email: mateusz.leszczak@hiossen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800000996059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233806

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: 2025-05-06
• Device Publish Date: 2025-04-28

On-Brand Devices [T2 Plus]

• 08800000996059: T2 PLUS is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray ge
• 08800000996042: T2 PLUS is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray ge