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Sirona Dental Orthophos S X-ray System - HSA Registration DE0505340

Access comprehensive regulatory information for Sirona Dental Orthophos S 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 DE0505340 and owned by Sirona Dental Systems GmbH. The device was registered on January 12, 2021.

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
DE0505340
Sirona Dental Orthophos S X-ray System
HSA Registration Number: DE0505340
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Product Description

The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry and pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and carpus exposures. Indications in dentistry areas: ● 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
DE0505340
Registration Date
January 12, 2021
Retention Due Date
January 11, 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 7 KAKI BUKIT ROAD 1, Eunos Techno Link, #03-06, SINGAPORE 415937
Model Information
Model Name(s)
Ceph SL arm left cpl Ceph SL arm right cpl Orthophos S 2D individ. Orthophos S 2D Orthophos S 3D individ. Orthophos S 3D 8x8 Orthophos S 3D 11x10 Orthophos S 2D Orthophos S 3D
Model Identifier(s)
6473123 6473438 6679596 6679604 6679612 6679620 6679638 6679646 6679653