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Dentium bright MCT Dental Extra-oral X-ray system - HSA Registration DE0507163

Access comprehensive regulatory information for Dentium bright MCT Dental Extra-oral 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 DE0507163 and owned by Dentium Co., Ltd. The device was registered on August 12, 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
DE0507163
Dentium bright MCT Dental Extra-oral X-ray system
HSA Registration Number: DE0507163
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Product Description

bright MCT is a computed tomography x-ray system intended to produce 3D and panoramic diagnostic images of the maxillofacial areas for treatment planning for adult and pediatric patients. The device is operated and used by physicians, dentists, and x- ray technicians. Rainbow 3D Image Viewer software features functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0507163
Registration Date
August 12, 2022
Retention Due Date
August 11, 2025
Product Owner
Short Name
Dentium Co., Ltd
Address
76, Changnyong-daero, 256beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16229, KOREA, REPUBLIC OF
Registrant
Address
20 HARBOUR DRIVE, PSA VISTA, #07-06, SINGAPORE 117612
Importer
Address
20 HARBOUR DRIVE, PSA VISTA, #07-06, SINGAPORE 117612
Model Information
Model Name(s)
bright MCT
Model Identifier(s)
ICT-R01-M