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 Ivoclar Vivadent, AG, Reliance Orthodontic Products, Inc. and Shofu Dental Corporation.
List of Agent, Tooth Bonding, Resin devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Agent, Tooth Bonding, Resin devices (product code KLE). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Dental FDA review panel. Browse all Dental devices →