510(k) K101617

FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL by Heraeus Kulzer, LLC — Product Code ELW

K101617 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, LLC for the device "FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL". The FDA issued a decision of Substantially Equivalent on September 7, 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.