Singapore HSA registration DE0501395
Sirona Dental ORTHOPHOS SL X-ray System
Singapore·CLASS C·Sirona Dental Systems GmbH·Registered March 16, 2018Device 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 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)
Product Owner
- Short Name
- Sirona
- Address
- Fabrikstrasse 31, D-64625 Bensheim, GERMANY
Registrant
- Name
- Fondaco Pte Ltd
- Address
- 7 KAKI BUKIT ROAD 1, Eunos Techno Link, #03-06, SINGAPORE 415937
Importer
- Name
- Fondaco Pte Ltd
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C