510(k) K123278

IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF by Heraeus Kulzer, LLC — Product Code KLE

K123278 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, LLC for the device "IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF". The FDA issued a decision of Substantially Equivalent on December 7, 2012. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Heraeus Kulzer, LLC has at least 10 other 510(k) clearances on record.