Device Dossier

32310000-0.5 cc, 32310001-1.0 cc, 32310002-2.0 cc, 32310003-4.0 cc, 32310004-1.0 cc, 32310005- 2.0 cc - Dental bone matrix implant, animal-derived

Device Dossier for 32310000-0.5 cc, 32310001-1.0 cc, 32310002-2.0 cc, 32310003-4.0 cc, 32310004-1.0 cc, 32310005- 2.0 cc - Dental bone matrix implant,…

Intended purpose

Device is a sterile, biocompatible anorganic porous porcine bone mineral matrix consisting predominantly of calcium phosphate for use in periodontal, oral and maxillofacial surgery.

Functional description

Augmentation or reconstructive treatment. Filling of infrabony periodontal defects. Filling of defects after root resection, apicoectomy, and cystectomy. Filling of extraction sockets. 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 product

TGA Public Summary