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This membrane is intended for use in oral surgical procedures as a resorbable material for augmentation around implants placed in immediate extraction sockets, augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation: alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection, cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

The TutoDent® Dental Membrane and CopiOs™ Pericardium Membrane are manufactured from bovine pericardium processed with the Tutoplast® process. These membranes are available in sizes ranging from 15 x 20mm to 30 x 40mm.

Tutopatch bovine pericardium is intended for the reinforcement of tissue during general and plastic surgery repair. The labeling reveals that the applicant and all predicate devices have the same intended use as a general and plastic surgery surgical mesh. Tutopatch bovine pericardium is intended for use to reinforce soft tissue where weakness exists in general and plastic surgery applications and is indicated for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: gastric banding, muscle flap reinforcement, repair of rectal prolapse using an abdominal approach (excluding rectocele), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, ventral, scrotal, and umbilical).

Tutopatch bovine pericardium is a Tutoplast® Processed, solvent-dehydrated gamma irradiated preserved bovine pericardium surgical mesh. Tutopatch bovine pericardium consists of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, it has a multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native tissue, while providing the basic formulative structure to support replacement by new endogenous tissue. Tutopatch bovine pericardium is supplied in sterile double-packaged peelable pouches and comes in a variety of sizes.