510(k) K081120

FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS by Kettenbach GmbH & Co. KG — Product Code ELW

K081120 is an FDA 510(k) premarket notification submitted by Kettenbach GmbH & Co. KG for the device "FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS". The FDA issued a decision of Substantially Equivalent on May 1, 2008. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Kettenbach GmbH & Co. KG has at least 10 other 510(k) clearances on record.