510(k) K083701

PANASIL INITIAL CONTACT AND PANASIL TRAY by Kettenbach GmbH & Co. KG — Product Code ELW

K083701 is an FDA 510(k) premarket notification submitted by Kettenbach GmbH & Co. KG for the device "PANASIL INITIAL CONTACT AND PANASIL TRAY". The FDA issued a decision of Substantially Equivalent on January 9, 2009. 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.