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SIRONA Dental Dentsply Sirona X-Smart System - HSA Registration DE0508705

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.

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CLASS B
DE0508705
SIRONA Dental Dentsply Sirona X-Smart System
HSA Registration Number: DE0508705
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Product Description

The device is used in dentistry to drive endodontic instruments for the mechanical preparation of the patientโ€™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.

Device 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 Owner
Short Name
Sirona Dental Systems GmbH
Address
FabrikstraรŸe 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