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 regulations ensures that customers and patients receive the highest level of safety and quality in our bone graft products.

Before we undergo our own processing, our bone material is sourced from the following AATB accredited tissue banks:

AlloSource
Centennial, CO

LifeNet
Virginia Beach, VA

Tissue Banks International
Baltimore, MD

South Texas Blood and Tissue Center
San Antonio, TX

After final packaging, each package of our products is sterilized by a validated electron beam (e-beam) method to a sterility assurance level of 10^-6. Sterility assurance level (SAL) means that the number 10^-6 denotes the number of products that will have a living microorganism following the sterilization process. In other words, once the sterilization is completed, an SAL of 10^-6 means that the odds of finding an unsterile product will be 1 in a million. While other sterilization methods such as dry heat, gamma irradiation, and ethylene oxide have also been shown to inactivate viruses, they can be detrimental to the biological and physical properties of allograft bone. Evidence indicates that e-beam sterilization does not negatively impact the DBM or its bioactivity at the doses used on our products.^{1, 2}

¹ Swenson CL, Arnoczky SP. Demineralization for inactivation of infectious retrovirus in systemically infected cortical bone. JBJS 2003;A(2):323-31.
² Wientroub S, Reddi AH. Influence of irradiation on the osteoinductive potential of demineralized bone matrix. Calif Tissue Int 1988;42:255-60.

No. Irradiation is known to be able to inflict damage, and too high a dose can actually kill the bioactivity of a graft. Our products are sterilized by e-beam irradiation, which is documented to be safe and maintains the integrity of the graft material. Other forms such as gamma irradiation have been documented as inflicting damage to the bone forming properties of the graft material.