510(k) K060889

SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE by Pentron Clinical Technologies — Product Code KIF

K060889 is an FDA 510(k) premarket notification submitted by Pentron Clinical Technologies for the device "SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE". The FDA issued a decision of Substantially Equivalent on October 27, 2006. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Pentron Clinical Technologies has at least 10 other 510(k) clearances on record.