510(k) K252151

els unibond by Saremco Dental AG — Product Code KLE

K252151 is an FDA 510(k) premarket notification submitted by Saremco Dental AG for the device "els unibond". The FDA issued a decision of Substantially Equivalent on December 5, 2025. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Saremco Dental AG has at least 3 other 510(k) clearances on record.