510(k) K231060

ProMin Dental Desensitizing Gel by Belport Company, Inc., Gingi-Pak — Product Code LBH

K231060 is an FDA 510(k) premarket notification submitted by Belport Company, Inc., Gingi-Pak for the device "ProMin Dental Desensitizing Gel". The FDA issued a decision of Substantially Equivalent on June 13, 2024. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Belport Company, Inc., Gingi-Pak has at least 10 other 510(k) clearances on record.