Device Dossier

OSSIX Agile - Collagen dental regeneration membrane

Device Dossier for OSSIX Agile - Collagen dental regeneration membrane (Collagen dental regeneration membrane, Class III, sponsor Dentsply Sirona). ARTG…

Intended purpose

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 and guided tissue regeneration procedures in periodontal defects.

Functional description

OSSIX Agile™ is a biodegradable and biocompatible collagen membrane produced from porcine pericardium. The collagen is cross-linked using a naturally-occurring sugar – D ribose.

TGA Public Summary