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Osstem Implant T2 Dental X-ray System - HSA Registration DE0507071

Access comprehensive regulatory information for Osstem Implant T2 Dental X-ray System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507071 and owned by OSSTEM IMPLANT Co., Ltd.. The device was registered on July 08, 2022.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0507071
Osstem Implant T2 Dental X-ray System
HSA Registration Number: DE0507071
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Product Description

Dental surgery and treatment plan, disorder of temporomandibular joint, bone fracture. In other words, T2-C, T2-CS, T2-C-P & T2-CS-P is a dental x-ray imaging system (digital) in which the x-ray projection signals are converted into digital signals to secure 3D images by reconstructing the 2D images using Panoramic, Cephalometric, and Computed Tomography technology (Pano, Ceph, and CT technology) with the purpose of diagnosing oral and maxillofacial anatomical structure.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0507071
Registration Date
July 08, 2022
Change Notification Approval Date
February 11, 2025
Retention Due Date
July 07, 2025
Product Owner
Short Name
OSSTEM IMPLANT Co., Ltd.
Address
2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, KOREA, REPUBLIC OF
Registrant
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #03-02, SINGAPORE 138565
Importer
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #03-02, SINGAPORE 138565
Model Information
Model Name(s)
T2 T2 Plus T2 T2 Plus
Model Identifier(s)
T2-C T2-C-P T2-CS T2-CS-P