Porcelain Etch Gel

Porcelain Etch Gel is an FDA 510(k)-cleared medical device (K260430) manufactured by Belport Company, Inc., Gingi-Pak. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 9, 2026. Regulation: 8.