510(k) K201309

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium by Mecta Corporation — Product Code JXL

K201309 is an FDA 510(k) premarket notification submitted by Mecta Corporation for the device "ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium". The FDA issued a decision of Substantially Equivalent on June 4, 2021. The device falls under product code JXL (Block, Bite), a Class II device regulated under 21 CFR 882.5070. Mecta Corporation has at least 1 other 510(k) clearance on record.