510(k) K261937

PacTemp Automix NE by The Belport Company Inc., DBA Gingi-Pak — Product Code EMA

K261937 is an FDA 510(k) premarket notification submitted by The Belport Company Inc., DBA Gingi-Pak for the device "PacTemp Automix NE". The FDA issued a decision of Substantially Equivalent on August 7, 2026. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275.