510(k) K240714

Insure® Universal; Insure® Universal Automix by Cosmedent, Inc. — Product Code EMA

K240714 is an FDA 510(k) premarket notification submitted by Cosmedent, Inc. for the device "Insure® Universal; Insure® Universal Automix". The FDA issued a decision of Substantially Equivalent on July 24, 2024. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Cosmedent, Inc. has at least 10 other 510(k) clearances on record.