Singapore HSA registration DE0507163
Dentium bright MCT Dental Extra-oral X-ray system
Singapore·CLASS C·Dentium Co., Ltd·Registered August 12, 2022Device 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 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.
Product Owner
- Name
- Dentium Co., Ltd
- 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
About this record
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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