TBS Allograft Bone Particulate is a premium, mineralized 50/50 cortical–cancellous allograft particulate blend (250–1000 µm) designed to support bone regeneration through osteoconduction and to remodel fully to host bone. The prefilled syringe features a perforated hydration cap for quick, clean, in-syringe hydration and precise chairside delivery—minimizing handling time and mess.
All tissues are collected, processed, stored, and distributed in accordance with the regulations of the US Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB).
Comprehensive serologic testing is performed on each donor. In addition, numerous microbiological cultures are performed and evaluated by a recovery tissue bank. The test results of serum and fungal culture have been checked by each recovery tissue bank as well as the manufacturer. All human tissues must perform communicable disease testing by a FDA registered laboratory and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improcement Amendments of 1988(CLIA) and 42 CFR part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services(CMS).
