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Sirona Dental ORTHOPHOS SL X-ray System - HSA Registration DE0501395

Access comprehensive regulatory information for Sirona Dental ORTHOPHOS SL 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 DE0501395 and owned by Sirona Dental Systems GmbH. The device was registered on March 16, 2018.

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
DE0501395
Sirona Dental ORTHOPHOS SL X-ray System
HSA Registration Number: DE0501395
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Product Description

The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry, including pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and for carpal 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
DE0501395
Registration Date
March 16, 2018
Retention Due Date
March 15, 2026
Product Owner
Short Name
Sirona
Address
Fabrikstrasse 31, D-64625 Bensheim, GERMANY
Registrant
Address
7 KAKI BUKIT ROAD 1, Eunos Techno Link, #03-06, SINGAPORE 415937
Importer
Address
7 KAKI BUKIT ROAD 1, Eunos Techno Link, #03-06, SINGAPORE 415937
Model Information
Model Name(s)
SIDEXIS 4 ORTHOPHOS SL 2D ORTHOPHOS SL 3D ORTHOPHOS SL 3D ORTHOPHOS SL 3D ORTHOPHOS SL 2D ORTHOPHOS SL ORTHOPHOS SL
Model Identifier(s)
6456532 6464957 6464973 6464999 6466580 6467042 6473123 6473438