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Dimensional Bioceramics™ (DB) Calcium Sulfate Device (CSD) is a bone graft substitute that is intended for use as a bone void filler for voids and gaps and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from a traumatic injury to the bone. DB-CSD is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). DB-CSD is a bone graft substitute that resorbs and replaced with bone during the healing process. DB-CSD is biodegradable and biocompatible and may be used in an infected site.

Dimensional Bioceramics (DB) Calcium Sulfate Device (CSD) [DB-CSD] Bone Void Filler Kit is provided sterile for single patient use. The Kit contains medical grade calcium sulfate powder and mixing solution in pre-measured quantities. When mixed together in a sterile mixing bowl, the resultant paste may be injected, digitally implanted, or applied to a mold to produce pellets. DB-CSD resorbs and is replaced with bone during the healing process. DB-CSD is a moldable, biocompatible, biodegradable, and resorbable calcium sulfate material that is to be applied directly to the intended sites. It may be used within an infected site. The critical specifications are chemistry, crystallinity, physical form, porosity, and solubility.