510(k) K160441

Identic and KromaFaze Alginate Dental Impression Materials by Kerr Corporation — Product Code ELW

K160441 is an FDA 510(k) premarket notification submitted by Kerr Corporation for the device "Identic and KromaFaze Alginate Dental Impression Materials". The FDA issued a decision of Substantially Equivalent on June 30, 2016. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Kerr Corporation has at least 10 other 510(k) clearances on record.