T2 Plus

Primary DI
08800000996042
Brand
T2 Plus
Company
Osstem Implant Co.,Ltd.
Model
T2-CS-P
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 unitactuates 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. TheX-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 secureimagery 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.
Published
2025-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OASX-Ray, Tomography, Computed, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OASX-Ray, Tomography, Computed, DentalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233806000T2 PlusOsstem Implant Co., Ltd.2024-09-06OAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800000996042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800000996042088000009960428800000996042

GMDN Terms#

Term, Definition table
TermDefinition
Stationary panoramic/tomographic dental x-ray system, digitalA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (201) 266 0657mateusz.leszczak@hiossen.com

Regulatory Flags#

DUNS number
694893867
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSK52025-09-04
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSK52025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSK52025-04-24
08800000996059T2 PlusT2-C-P2025-04-28
08800209338841Estar-ZEZEHTA2012M2024-12-03
08800209338865Estar-ZEZEHTA2014M2024-12-03
08800209338889Estar-ZEZEHTA2016M2024-12-03
08800209338902Estar-ZEZEHTA2018M2024-12-03
08800209338926Estar-ZEZEHTA2020M2024-12-03
08800209338940Estar-ZEZEHTA2022M2024-12-03
08800209338964Estar-ZEZEHTA2025M2024-12-03
08800209338988Estar-ZEZEHTA2030M2024-12-03
08800209339008Estar-ZEZEHTA3010M2024-12-03
08800209339022Estar-ZEZEHTA3012M2024-12-03
08800209339046Estar-ZEZEHTA3014M2024-12-03
08800209339060Estar-ZEZEHTA3016M2024-12-03
08800209339084Estar-ZEZEHTA3018M2024-12-03
08800209339107Estar-ZEZEHTA3020M2024-12-03
08800209339121Estar-ZEZEHTA3022M2024-12-03
08800209339145Estar-ZEZEHTA3025M2024-12-03

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