510(k) K201127

DEFEND Ear-loop Face Masks by Young Dental Manufacturing Co. 1, LLC — Product Code FXX

K201127 is an FDA 510(k) premarket notification submitted by Young Dental Manufacturing Co. 1, LLC for the device "DEFEND Ear-loop Face Masks". The FDA issued a decision of Substantially Equivalent on April 14, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Young Dental Manufacturing Co. 1, LLC has at least 10 other 510(k) clearances on record.