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 Mediclus Co., Ltd..
FDA 510(k) Cleared Agent, Tooth Bonding, Resin Devices (Product Code KLE)
About Product Code KLE - Regulatory Context
510(k) Submission Activity
418 total 510(k) submissions under product code KLE since 1976, with 418 receiving FDA clearance (average review time: 84 days).
Submission volume has remained relatively stable over the observed period, with 13 submissions in the last 24 months.
FDA Review Time
Recent submissions under KLE have taken an average of 123 days to reach a decision - up from 83 days historically. Manufacturers should account for longer review timelines in current project planning.
KLE devices are reviewed by the Dental panel. Browse all Dental devices →