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Nobel Biocare DTX Studio™ Clinic - HSA Registration DE0510362

Access comprehensive regulatory information for Nobel Biocare DTX Studio™ Clinic in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510362 and owned by Nobel Biocare AB. The device was registered on February 20, 2025.

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 B
DE0510362
Nobel Biocare DTX Studio™ Clinic
HSA Registration Number: DE0510362
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Product Description

DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information. It can be used to assist in the detection of the suspected dental findings and to provide design input for dental restorative solutions

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0510362
Registration Date
February 20, 2025
Retention Due Date
February 19, 2026
Product Owner
Short Name
Nobel Biocare AB
Address
PO Box 5190, 402 26, Västra Hamngatan 1, 411 17 Göteborg,, SWEDEN
Registrant
Address
7500A BEACH ROAD, THE PLAZA, #09-308, SINGAPORE 199591
Importer
Address
13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905 13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905
Model Information
Model Name(s)
DTX Studio Clinic DTX Studio Clinic
Model Identifier(s)
300851_V4.3_MAC 300851_V4.3_WIN64