Datum Dental Ossix Agile Cross-linked pericardium membrane - HSA Registration DE0509397
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.
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.