510(k) K243254

Parkell Pit and Fissure Sealant by Parkell, Inc. — Product Code EBC

K243254 is an FDA 510(k) premarket notification submitted by Parkell, Inc. for the device "Parkell Pit and Fissure Sealant". The FDA issued a decision of Substantially Equivalent on August 8, 2025. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. Parkell, Inc. has at least 10 other 510(k) clearances on record.