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Sirona Dental Axeos X-ray System - HSA Registration DE0506849

Access comprehensive regulatory information for Sirona Dental Axeos X-ray System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506849 and owned by Sirona Dental Systems GmbH. The device was registered on May 11, 2022.

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 C
DE0506849
Sirona Dental Axeos X-ray System
HSA Registration Number: DE0506849
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Product Description

The X-ray system creates data for digital exposures in the maxillofacial region and subregions for dentistry and pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and for carpal exposures. Indications in sub-fields of dentistry: ● Conservative dentistry ● Endodontics ● Periodontology ● Prosthodontics / template scan exposures ● Functional diagnosis and therapy of craniomandibular dysfunctions ● Surgical dentistry ● Implantology ● Oral and maxillofacial surgery ● Orthodontics ● Pediatric dentistry ● ENT medicine (hard-tissue diagnostics)

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0506849
Registration Date
May 11, 2022
Retention Due Date
May 10, 2026
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)
Axeos (ww) Axeos (individ.) Ceph arm right cpl. Ceph arm left cpl. Retrofit Ceph arm left cpl. Retrofit Ceph arm right cpl.
Model Identifier(s)
6728914 (6728930) 6728922 (6728930) 6732981 6732999 6758481 6758531