How safe are Keystones allograft products?
Keystone Dental is dedicated to delivering the utmost quality in our bone grafting products and ensuring patient safety. Our products undergo processing steps to make the risk of disease transmission extremely remote. We strictly adhere to tissue banking standards as provided by the: • Food and Drug Administration (FDA) • American Association of Tissue Banks (AATB) • Clinical Laboratory Improvement Amendments (CLIA) Sterilization is achieved through electron beam (e-beam) irradiation after packaging is complete to destroy any microorganisms without negatively affecting the bioactivity of our DBM products. Keystone’s bone grafting substitute products contain demineralized bone matrix (DBM). DBM has been used safely for 50 years. Our products are manufactured by IsoTis OrthoBiologics and to quote IsoTis, “To date, IsoTis’ bone graft substitutes have been used safely and effectively in more than 250,000 patients.” Adherence to strict donor-screening and tissue-testing standards and regula
