FDA Product Code KLE: Agent, Tooth Bonding, Resin

FDA product code KLE covers resin-based dental bonding agents used to bond composite restorations and porcelain veneers to tooth structure.

These multi-step or all-in-one adhesive systems create a micromechanical and chemical bond between the dentin/enamel substrate and the restorative material. They are an essential component of modern adhesive dentistry and direct composite restoration.

KLE devices are Class II medical devices, regulated under 21 CFR 872.3200 and reviewed by the FDA Dental panel.

Leading manufacturers include Spident Co., Ltd., Rizhao Huge Biomaterials Company, Ltd. and GC America, Inc..