Singapore HSA registration DE0508705
SIRONA Dental Dentsply Sirona X-Smart System
Singapore·CLASS B·Sirona Dental Systems GmbH·Registered November 30, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0508705
- Registration Date
- November 30, 2023
- Change Notification Approval Date
- April 04, 2025
- Retention Due Date
- November 29, 2025
Product description
The device is used in dentistry to drive endodontic instruments for the mechanical preparation of the patient’s root canal and cavity. Some models incorporate an electronic apex locator that assists the operator to locate the file tip inside the root canal.
Product Owner
- Short Name
- Sirona Dental Systems GmbH
- Address
- Fabrikstraße 31, 64625 Bensheim, GERMANY
Registrant
- Address
- 1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Importer
- Address
- 1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Model information
- Model Name(s)
- X-Smart Pro X-Smart Pro+
- Model Identifier(s)
- 6779008 6779016
About this record
Access comprehensive regulatory information for SIRONA Dental Dentsply Sirona X-Smart System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508705 and owned by Sirona Dental Systems GmbH. The device was registered on November 30, 2023.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B