510(k) K113711

LIME-LITE II by Pulpdent Corporation — Product Code EJK

K113711 is an FDA 510(k) premarket notification submitted by Pulpdent Corporation for the device "LIME-LITE II". The FDA issued a decision of Substantially Equivalent on March 5, 2012. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. Pulpdent Corporation has at least 10 other 510(k) clearances on record.