Osteotech's DBM products:
This article was originally published in Clinica
Executive Summary
Osteotech has received from the US FDA three 510(k) marketing clearances for demineralised bone grafts in its DBM family of products. One clearance is for its Viagraf DBM paste, for use in filling bone defects in the extremities that might have been created surgically or by traumatic injury to the bone. The other two clearances cover the firm's Grafton Plus DBM paste for use in orthopaedic procedures and for use in dental, oral and cranio/maxillofacial procedures. The Eatontown, New Jersey firm has two more 510(k) applications for its DBM product pending clearance.