Device Dossier

Cranofacial fixation plate, non-biodegradable

Device Dossier for Cranofacial fixation plate, non-biodegradable (Cranofacial fixation plate, non-biodegradable, Class IIb, sponsor Dentsply Sirona).…

Intended purpose

BoneShields are used for bone augmentation procedures in patients with inadequately dimensioned bones. BoneShields are used to fixate augmented areas and to prevent dislocation of bone graft material, soft tissue invasion and to shelter the space underneath the membrane from physical stress of overlaying tissue. BoneShields are intended for the management of hard and/or soft tissue

TGA Public Summary