T2 Plus
Basic Information
- Brand Name
- T2 Plus
- Primary DI
- 08800000996042
- Version / Model
- T2-CS-P
- Company Name
- Osstem Implant Co.,Ltd.
- Labeler DUNS
- 694893867
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-28
- Public Version
- 1
- Public Version Date
- 2025-05-06
- Public Version Status
- New
- Public Device Record Key
- a1213ee1-5884-423a-8685-1ea499202fe1
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | Radiology | 892.1750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44245 | Stationary panoramic/tomographic dental x-ray system, digital | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800000996042 | GS1 |
Customer Contacts
- Phone
- +1 (201) 266 0657
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233806 | 000 |