Singapore HSA registration DE0505340
Sirona Dental Orthophos S X-ray System
Singapore·CLASS C·Sirona Dental Systems GmbH·Registered January 12, 2021Device 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 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).
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C