◦ Implantology: for antrostomy coverage and for the protection of grafts carried out in defects
of two walls.
◦ Periodontology: graft protection in defects infraosseous when the suture of the edges presents
risk of exposure.
Provides stabilization in the graft area and a long-lasting protection against external agents. In the sinus lift with lateral access, the membrane is indicated to cover the antrostomy and protect the sinus membrane at risk of laceration due to graft pressure. Can also be used for protect perimplant regeneration and grafts periodontal.
PRESENTATION:
10x15mm x 1mm, 15x20mm x 1mm or 20x30mm x 1mm units. Sealed blister packaging.
Intended Uses
◦ Augmentation / reconstruction of the alveolar ridge.
◦ Post-extraction socket filling.
◦ Implantology: preparation of implant sites, filling of bone dehiscences and elevation of the maxillary sinus floor.
Safety and Efficacy of the Medical product
The certification of the animals from which the raw material comes are originally raised, fed and slaughtered within the territory of the Argentine Republic. The raw material is kept stored in freezers with installed thermal controllers that ensure the storage conditions and keep the pig tissue within the parameters established in the product monograph.
Verification and validation reports demonstrate that the device meets predetermined performance requirements. Clinical evidence is included in the product development process and demonstrates that the device is suitable for its intended use.
Risk Analysis was used in all design phases to ensure that safety principles were adequately addressed.