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Synthetic Bone Graft Particulate is intended to be used to augment the alveolar bone in tooth extraction procedures. (i.e., use in extraction sockets only)

Synthetic Bone Graft Particulate is a synthetic absorbable osteoconductive bone graft substitute manufactured from 45S5 bioactive glass. The device is in particulate form with a size range of 0.5 mm to 1 mm. The device is intended for augmenting alveolar bone in tooth extraction procedures. At time of use, the device is mixed with sterile saline to form a wet sandy paste that is applied to the defect. Synthetic Bone Graft Particulate is progressively resorbed and replaced by new bone tissue during the healing process. It is supplied sterile, packaged in a rubber stopper-sealed glass bottle within a sterile barrier package (Tyvek-sealed PETG box). The device packages are protected by carboard box.

CMFlex™ is indicated for filling and/or augmenting maxillofacial, mandibular, and intraoral osseous defects. Indications include: - Intrabony periodontal osseous defects - Furcation defects - Bony defects or bony deficiencies of the alveolar ridge - Intraoral, maxillofacial, and mandibular augmentation - Bony defects of the upper or lower jaw - Filling of tooth extraction sites - Sinus elevation grafting

CMFlex™ is a synthetic bone grafting material provided in block form of varying sizes (See Table 1.1) that can be easily trimmed or cut by the surgeon to fit the patient's bone defect(s). CMFlex™ is composed of majority synthetic hydroxyapatite powder bound by minority biodegradable polylactide-co-glycolide. CMFlex™ is fabricated via extrusion-based 3D-printing of liquid inks into regular porous structures. The combined macroscopic 3D-printed porosity, microporosity within the printed struts, and micron-sized hydroxyapatite particles gives CMFlex unique microstructural and physical properties. CMFlex™ is an osteoconductive, highly absorbent, and flexible bone graft that can be used in defects where new bone is needed. Although it is not intended for immediate load bearing applications, the implant remodels over time and is replaced by new bone tissue, functioning in the same manner as the predicate device. The blocks are provided sterile and are intended for single use. There are no accessories associated with CMFlex™.

InRoad® Dental Synthetic Bone Graft is intended for the filling and reconstruction of multi-walled bone defects such as: - Defects after removal of bone cysts - Augmentation of the atrophied alveolar ridge - Sinus lift and sinus floor elevation (subantral augmenation) - 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 infra-bony 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

InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense porous bioceramic for bone regeneration. It is comprised of 90 ± 5% hydroxyapatite (HA) and 10 ± 5% ß-Tricalcium Phosphate (B-TCP). The granules are provided sterile (gamma irradiated) in a capped vial packaged in a sealed tray with lid. InRoad® Dental SBG granules are designed to resemble trabecular bone structure. The granule structure consists of interconnected primary open pores, a secondary channel-like structure, and tertiary small holes on the surface resulting in a biocompatible, osteoconductive biomaterial. The multi-porous structure of InRoad® Dental SBG makes it possible for the bone cells to migrate into the matrices and for new bone to grow. InRoad® Dental Synthetic Bone Graft is available in granule form in sizes of 0.3 - 1.0 mm (Small) and 0.8 - 1.8 mm (Large).

OsOpia is a bone grafting material indicated for use in the specific treatment of extraction sockets and maxillary sinus augmentation procedures.

OsOpia is a synthetic, > 90% TCP (Tri-Calcium Phosphate - Ca3(PO4)2) and < 10% Hydroxyapatite (Ca10(PO4)6 (OH)2) resorbable micro-structured bone grafting material for the repair of bony defects. OsOpia induces and guides the three-dimensional regeneration of bone in the defect site into which it is implanted. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all planes (e.g. bioresorbable barrier membranes). When placed next to viable host bone, new bone will be deposited on the surface of the implant resorbs and is replaced by bone during the natural process of bone remodelling. OsOpia is gamma sterilized, comes in several sizes in granular form, and is double sterile packaged for single use only.

Straumann® BoneCeramic is indicated for filling and/or augmenting the following intraoral/maxillofacial osseous defects: - Intrabony periodontal osseous and furcation defects - Augmentation of bony defects of the alveolar ridge ● - Filling tooth extraction sites ● - Sinus elevation grafting .

Straumann® BoneCeramic is a fully synthetic bone graft substitute of medical grade purity in particulate form composed of biphasic calcium phosphate. It consists of a mixture of 60% hydroxyapatite (HA), which is 100% crystalline, and of 40% of the beta form of tricalcium phosphate (beta-TCP). BoneCeramic is 90% porous with interconnected pores of 100-500 microns in diameter. It is osteoconductive and gradually resorbed and replaced by vital bone during bone remodeling. BoneCeramic is available in two granule sizes: 400-700 µm diameter and 500-1000 µm diameter and in three different filling volumes: 0.25g, 0.5g and 1.0g. It is delivered sterile.

-Augmentation or reconstructive treatment of the alveolar ridge. -Filling of periodontal defects. -Filling of defects after root resection, apicocetomy, 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 Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). -Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Cytrans Granules is composed of carbonate apatite. The material of Cytrans Granules has been formulated in terms of carbonate apatite content to the mineral content of natural bone. As Cytrans Granules is completely synthetic, there are no animal derived ingredients in the formula. Cytrans Granules is gradually resorbed and eventually replaced with new bone. Resorption is by osteoclasts under acidic conditions. Cytrans Granules is manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. It is sterilized via gamma irradiation and will be marketed/sold in sterile vials for single use.

OSTEON III is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects. - Periodontal/infrabony defects - Ridge augmentation - Extraction Sites(implant preparation/ placement) - Sinus lifts - Cystic cavities

This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (ß-TCP). This product presents an interconnected porous structure, similar to that human cancellous bone. This product is available as irregular shape particle of size 0.2~2.0mm. It is sterilized by gamma-radiation.

ShefaBone SCPC Resorbable Bioactive Bone Graft, is a silica-calcium phosphate composite, synthetic bone graft material for use in oral, dental intraosseous, and maxillofacial bone defects. Typical uses include: - Periodontal / infrabony defects - Ridge augmentation (sinusotomy, osteotomy, cystectomy) - Extraction sites (ridge maintenance/augmentation, implant preparation/ placement) - Sinus lifts - Cystic cavities - Oral and maxillofacial augmentation

ShefaBone SCPC Resorbable Bioactive Bone Graft, is a silica-calcium phosphate composite, synthetic bone graft material. It is resorbable and has a porous structure with a particle size of 90-710 micron. It is processed by thermal treatment to bond the chemical components together. It is packaged in a sealed glass vial containing 1 gm (1cc) of SCPC particles, sealed in an aluminum sterilization pouch, and sterilized by Gama radiation.

MASTERGRAFT® Putty is combined with either sterile water and/or autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Putty is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Procedures include: - o Filling of periodontal defects - Filling of dental extraction sockets o - Filling of cystic defects o - o Sinus lifts - o Alveolar ridge augmentation - O Oral/maxillofacial augmentation or reconstruction. MASTERGRAFT® Putty may be used with or without internal fixation, and maybe mixed with autograft as a bone graft extender.

MASTERGRAFT® Putty is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. The collagen component in the MASTERGRAFT® Putty device is Type I bovine collagen. The biphasic ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß tricalcium phosphate formulation. MASTERGRAFT® Putty is supplied as a sterile, dry, solid, construct that is hydrated for single patient use and is a moldable form of bone void filler. MASTERGRAFT® Putty is a osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is biocompatible. MASTERGRAFT® Putty has been shown to heal bone defects.

Bond Apatite™ is a synthetic osteoconductive, bioresorbable bone grafting material composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form. intended to fill. augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Bond Apatite is composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form. The hydroxyapatite component is sintered hydroxyapatite granules that conform to ISO 13779-1 Implants for surgery - Hydroxyapatite - Part 1: Ceramic Hydroxyapatite and ISO 13779-3 Implants for surgery – Hydroxyapatite – Part 3: Chemical analysis and characterization of crystallinity and phase purity. The calcium sulfate material is Bond Bone™, a mixture of surgical grade calcium sulfate dihydrate and calcium sulfate hemihydrate, and cleared under K083858. The calcium suffate component conforms to the chemical requirements of ASTM F2224 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants. Bone Apatite is provided sterile, in a single unit size of 1 cc in a disposable applicator that is used for mixing the dry powder with sterile saline and for delivery to the treatment site.