Osteotech receives fifth FDA clearance for dental products

By Lisa Kerner

Erie, Pa., Jan. 9 - Osteotech, Inc. announced today that the Food and Drug Administration has cleared Osteotech's fifth 510(k) submission for its family of DBM products.

This latest 510(k) submission covers Osteotech's Grafton DBM Gel, Putty, Flex, Matrix and Crunch products. These tissue forms can be used in dental, oral and cranio/maxillofacial procedures to fill and/or augment bone defects created surgically or by traumatic injury.

Osteotech successfully filed five separate 510(k) applications between late 2004 and mid 2005, according to a company news release.

Osteotech provides human bone and bone connective tissue for transplantation. The company, based in Eatontown, N.J., also markets biomaterial and implant products for musculoskeletal surgery.

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