510(k) K260430

Porcelain Etch Gel by Belport Company, Inc., Gingi-Pak — Product Code KLE

K260430 is an FDA 510(k) premarket notification submitted by Belport Company, Inc., Gingi-Pak for the device "Porcelain Etch Gel". The FDA issued a decision of Substantially Equivalent on April 10, 2026. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Belport Company, Inc., Gingi-Pak has at least 10 other 510(k) clearances on record.