Biomaterial manufacturer and marketer Datum Dental has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Ossix Volumax scaffold.
Ossix Volumax is a volumizing, resorbable collagen scaffold.
Because the scaffold is designed to improve bone growth, it can be used in periodontics, oral surgery, implantology, and for aesthetic procedures, according to the company. It is available in four sizes, ranging from 10 x 12.5 mm to 30 x 40 mm.
OraPharma will distribute Ossix Volumax in the U.S.