Orantech Inc. TA-FDA-2AD05 Orantech

Device Name: Curasan OSSEOLIVE® DENTALlndications for Use:OSSEOLIVE® DENTAL is indicated for applications in oral andmaxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled(artificial or degenerative) bone defects, e.g.:- Defects after the extirpation of bone cysts- Augmentation of an atrophied alveolar ridge- Sinus lift or sinus floor elevation (subantral augmentation)- Filling of alveolar defects after tooth extraction for preservation of the alveolar ridge- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects- Defects after operative removal of retained teeth or corrective osteotomies

Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes

Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)