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The SurFuse ™ II Putty and ExFuse ™ II Putty are bone filling materials indicated for dental intraosseous, oral and maxillofacial defects, including periodontal/infrabony defects; alveolar ridge augmentation; dental extraction sites; sinus lifts; cystic defects.

The SurFuse ™ II Putty and ExFuse ™ II Putty are derived from human allograft bone tissue that is processed into a powder and demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a resorbable carrier, carboxymethylcellulose (CMC) and formulated into a putty-like consistency. The ExFuse ™ II Putty also contains cancellous bone powder. They are provided sterile for single patient use. The products are provided sterile for single patient use.

RegenerOss Allograft Putty Plus Mineralized is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including: localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects.

Bone Filling Material used for augmenting deficient bone or filling bone defects in oral/dental applications. Allograft (Bone) Putty containing human allograft bone tissue (DBM) and mineralized cancellous chips, from the same donor, combined with a lipid carrier.

DBX® Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used as follows: Ridge augmentation Filling of extraction sites Craniofacial augmentation Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture Filling resection defects in benign tumors, benign cysts, or other osseous defects in the alveolar ridge wall Filling of cystic defect Filling of lesions of periodontal origin Filling of defects of endodontic origin DBX® Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Inject can be used with bone marrow. DBX® Inject is for single patient use only.

DBX® Inject is osteoconductive, and has been shown to have osteoinductive potential in an athymic mouse model. Every lot of final DBX® Inject Paste will be assayed in vivo for osteoinductive potential. - Every lot of final DBX® Inject Putty product will be tested in an athymic mouse model or in an alkaline phosphatase assay, which has been shown to have a positive correlation with the athymic mouse model, to ensure the osteoinductive potential of the final product. Standard testing performed in an athymic mouse or alkaline phosphatase assay must prove positive for lot release. It is unknown how the osteoinductive potential, measured in the athymic mouse model or the alkaline phosphatase assay, will correlate with clinical performance in human subjects. DBX® Inject is single-donor processed. The donor suitability criteria used to screen this donor are in compliance with the FDA regulations published in 21 CFR Part 1270 and Part 1271 Human Tissue Intended for Transplantation.

PROGENIX® DBM Putty and PROGENIX® Plus may be used alone or in combination with autograft bone and/or autogenous bone marrow for use as a bone graft extender. substitute, and bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure, of the cranial, oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX® DBM Putty and PROGENIX® Plus provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. PROGENIX® DBM Putty and PROGENIX® Plus are intended to be used alone or in combination with autogenous bone and/ or bone marrow aspirate for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of cranial oral maxillofacial and dental intraosseous defects including but not limited to: Ridge augmentation Filling of cystic defect Filling of extraction sites Filling of lesions of periodontal origin Craniofacial augmentation Filling of defects of endodontic origin Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

The PROGENIX® products contain human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX® is available in two versions: Putty and Plus. The PROGENIX® Plus version contains two different sized demineralized bone particles. PROGENIX® DBM Putty and PROGENIX® Plus are single use products intended for use in the oralmaxillofacial region. Additionally, these products are not designed to impart any mechanical strength to the surgical site. Both versions are provided in readyto-use malleable forms that may be molded or manipulated by the surgeon into various shapes. These products have been shown to be osteoinductive in an athymic rat assay. as well as osteoconductive, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

PROGENIX® DBM Putty and PROGENIX® Plus are intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to: Ridge augmentation Filling of cystic defect Filling of extraction sites Filling of lesions of periodontal origin Craniofacial augmentation Filling of defects of endodontic origin Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

PROGENIX® contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX® is available in two forms: Putty and Plus. The PROGENIX® Plus version contains two different sized demineralized bone particles. PROGENIX® DBM Putty and PROGENIX® Plus are single use products intended for use in the oralmaxillofacial region. Additionally, these products are not designed to impart any mechanical strength to the surgical site. Both versions are provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. These products have been shown to be osteoinductive in an athymic rat assay, as well as osteoconductive, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

PROGENIX™ DBM Putty is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to: Ridge augmentation Filling of cystic defect Filling of extraction sites Filling of lesions of periodontal origin Craniofacial augmentation Filling of defects of endodontic origin Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

PROGENIX™ DBM Putty contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. All DBM used in the preparation of PROGENIX™ DBM Putty must induce bone formation when evaluated in a validated athymic nude rat assay. Although, findings from an animal model are not necessarily predictive of human clinical results. PROGENIX™ DBM Putty is a single use product intended for use in the oralmaxillofacial region. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX™ DBM Putty is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing

These products are intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including - . Periodontal defects; - . Alveolar ridge augmentation; - Extraction sockets (ridge preservation, implant preparation/ placement); . - . Maxillary sinus floor elevation; - Craniofacial augmentation; . - Root resection, apicoectomy and cystectomy; . - Tumor resection. . One or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site.

Regenafil®, Altiva DBM Paste, BioSet™, RTI Allograft Paste, and Osteofil® contain human demineralized freeze-dried bone allograft (DFDBA, also known as demineralized bone matrix, DBM) in an inert porcine gelatin carrier. Regenaform®, Altiva DBM with cortical cancellous chips, BioSet™ IC, RTI Allograft Paste IC, and Osteofil® ICM contain human DFDBA and human cortical-cancellous bone chips in an inert porcine gelatin carrier.

InterGro® Oral is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including: localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects.

InterGro® Oral is a resorbable, osteoconductive, and osteoinductive bone graft substitute that resorbs and is replaced with bone during the healing process. Its main component, demineralized cortical bone matrix (DBM), is derived from donor human tissue (allograft bone) and contains various growth factors including osteoinductive proteins. The DBM has been granulated, lyophilized and aseptically processed. In some versions of the product, calcium salt granules shall be incorporated to provide additional osteoconduction and enhanced structural strength. The carrier for InterGro® Oral is a resorbable, biocompatible, semi-viscous lipid. InterGro® Oral is provided ready-to-use in various physical consistencies. It is packaged in various sizes by volume for single patient use.

OrthoBlast® It DBM Paste and Putty are bone filling materials indicated for augmentation or reconstructive treatment of alveolar ridge. This includes: - Filling of defects after root resection, apicoectomy and cystectomy ・ - Filling of extraction sockets to enhance preservation of the alveolar ridge - - Elevation of maxillary sinus floor -

OrthoBlast® II DBM Paste and Putty is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or puttylike consistency. OrthoBlast® II DBM Paste and Putty are osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.