Singapore HSA registration DE0509397
Datum Dental Ossix Agile Cross-linked pericardium membrane
Singapore·CLASS D·Datum Dental Ltd.·Registered June 14, 2024Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0509397
- Registration Date
- June 14, 2024
- Change Notification Approval Date
- March 25, 2025
- Retention Due Date
- June 13, 2025
Product description
OSSIX Agile™ membrane alone or in combination with suitable augmentation materials (like autologous bone or other bone replacement materials) is indicated for immediate or delayed guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable membrane for: • Alveolar ridge augmentation and reconstruction, • Alveolar ridge preservation consequent to tooth extractions, • Over the window in sinus elevation procedures and for support of the Schneiderian membrane, • In intrabony defects around teeth, • Guided tissue regeneration procedures in periodontal defects.
Product Owner
- Short Name
- Datum Dental Ltd.
- Address
- 38 Hayarkon St., 8122741 Yavne, ISRAEL
Registrant
- Address
- 1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Importer
- Address
- 1 IRVING PLACE, THE COMMERZE@IRVING, #05-08, SINGAPORE 369546 1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Model information
- Model Name(s)
- OSSIX Agile™ OSSIX Agile™ OSSIX Agile™ OSSIX Agile™
- Model Identifier(s)
- 68018004 68018005 68018006 68018007
About this record
Access comprehensive regulatory information for Datum Dental Ossix Agile Cross-linked pericardium membrane in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0509397 and owned by Datum Dental Ltd.. The device was registered on June 14, 2024.
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 D