510(k) K102770

FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW by Heraeus Kulzer, LLC — Product Code ELW

K102770 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, LLC for the device "FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW". The FDA issued a decision of Substantially Equivalent on December 21, 2010. 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.