HSA · registration DE0510362Nobel Biocare DTX Studio™ Clinic
SingaporeDentalClass BNobel Biocare AB
Official record identity
- Registration number
- DE0510362
- Model name
- DTX Studio Clinic; DTX Studio Clinic
- Model identifier
- 300851_V4.3_MAC; 300851_V4.3_WIN64
- Registration date
- February 20, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Nobel Biocare AB
- Registrant / registration holder
- EHC COMMERCIAL SINGAPORE PTE. LTD.
Official 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
Additional source fields
- Product owner address
- PO Box 5190, 402 26, Västra Hamngatan 1, 411 17 Göteborg,, Sweden
- Registrant address
- 13 STAMFORD ROAD, #02-11, CAPITOL PIAZZA, Singapore 178905
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.