510(k) K120914

FLEXITIME FAST & SCAN LIGHT FLOW by Heraeus Kulzer, LLC — Product Code ELW

K120914 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, LLC for the device "FLEXITIME FAST & SCAN LIGHT FLOW". The FDA issued a decision of Substantially Equivalent on July 25, 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.