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Singapore HSA registration DE0018176

Sirona XIOS Scan System

Singapore flagSingapore·CLASS B·Sirona Dental Systems GmbH·Registered May 31, 2016
Device classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration information
Registration Number
DE0018176
Registration Date
May 31, 2016
Change Notification Approval Date
September 14, 2017
Retention Due Date
May 30, 2025
Product description
This system, when combined with an intraoral X-ray tube assembly, is used to create digital intraoral X-ray scans. Indications in the areas: ● Conservative dentistry ● Caries diagnosis, especially of proximal lesions ● Endodontics ● Periodontology ● Prosthodontics ● Functional diagnosis and therapy of craniomandibular dysfunctions ● Surgical dentistry ● Implantology ● Oral and maxillofacial surgery ● Orthodontics
Product Owner
Name
Sirona Dental Systems GmbH
Short Name
Sirona Dental Systems GmbH
Address
Fabrikstrasse 31, 64625 Bensheim, GERMANY
Registrant
Name
DENTSPLY SIRONA SINGAPORE PTE LTD
Address
1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Importer
Name
DENTSPLY SIRONA SINGAPORE PTE LTD Fondaco Pte Ltd
Address
1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881 7 KAKI BUKIT ROAD 1, Eunos Techno Link, #03-06, SINGAPORE 415937
Model information
Model Name(s)
XIOS Scan Image Plate Size 0 (2 pcs.) XIOS Scan Image Plate Size 1 (2 pcs.) XIOS Scan Image Plate Size 2 (2 pcs.) XIOS Scan Image Plate Size 3 (2 pcs.) XIOS Scan Hygienic Covers Size 0 (100 pcs.) XIOS Scan Hygienic Covers Size 1 (100 pcs.) XIOS Scan Hygienic Covers Size 2 (100 pcs.) XIOS Scan Hygienic Covers Size 3 (100 pcs.) XIOS Scan Bite Protection Cover Size 0 (100 pcs.) XIOS Scan Bite Protection Cover Size 1 (100 pcs.) XIOS Scan Bite Protection Cover Size 2 (100 pcs.) XIOS Scan Bite Protection Cover Size 3 (100 pcs.) XIOS Scan Transport Box without Mat Xios scan plugin CD XIOS Scan XIOS Scan Mat for Transport Box
Model Identifier(s)
6479039 6479047 6479054 6479062 6479278 6479286 6479294 6479302 6490572 6490580 6490598 6490606 6492503 6492511 6492735 6526730
About this record

Access comprehensive regulatory information for Sirona XIOS Scan 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 DE0018176 and owned by Sirona Dental Systems GmbH. The device was registered on May 31, 2016.

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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