Datum Dental OSSIX® Resorbable Collagen Membrane - HSA Registration DE0019357
Access comprehensive regulatory information for Datum Dental OSSIX® Resorbable Collagen 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 DE0019357 and owned by Datum Dental Ltd.. The device was registered on June 23, 2017.
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.
A resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for: 1. Ridge augmentation for later implant insertions. 2. Simultaneous ridge augmentation and implant insertions. 3. Ridge augmentation around implants inserted in delayed extraction sites. 4. Ridge augmentation around implants inserted in immediate extraction sites. 5. Alveolar ridge preservation consequent to tooth (teeth) extraction(s). 6. Over the window in lateral window sinus elevation procedures. 7. In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved. 8. In intra bony defects around teeth. 9. For treatment of recession defects, together with coronally positioned flap. 10. In furcation defects in multi rooted teeth. OSSIX® Volumax is also indicated for localized gingival augmentation.