510(k) K113574

FLEXITIME MONOPHASE PRO SCAN by Heraeus Kulzer, LLC — Product Code ELW

K113574 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, LLC for the device "FLEXITIME MONOPHASE PRO SCAN". The FDA issued a decision of Substantially Equivalent on July 13, 2012. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Heraeus Kulzer, LLC has at least 10 other 510(k) clearances on record.