ISOTIS GETS 510(K) FOR DYNAGRAFT II DENTAL

IsoTis OrthoBiologics has received FDA 510(k) clearance for the use of DynaGraft II in dental applications.

DynaGraft II is a combination of demineralized bone matrix (DBM) in a reverse phase medium. The reverse phase medium becomes more viscous at body temperature, but less viscous at cooler temperatures. For example, the product is malleable at operating room temperatures, yet thickens when placed in the operative site. This allows the DBM to be contained at the graft site with minimal loss through irrigation and suction.

Irvine, Calif.-based IsoTis previously received FDA 510(k) clearance for the use of DynaGraft II in orthopedic applications in April.