Enamel Bonding System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K020050 ↗

FDA Product Code

KLE

Device Class

Class II

Regulation

21 CFR Part 872.3200

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Zinc Phosphate Cement

  Class II

  FDA 510(k) K003427 Active Cleared 24 Jan 2001

• Tooth Shade Resin Material

  Class II

  FDA 510(k) K011453 Active Cleared 23 Jul 2001

• Cavity Varnish

  Class II

  FDA 510(k) K010255 Active Cleared 20 Apr 2001

• Alginate Impression Material

  Class II

  FDA 510(k) K003426 Active Cleared 23 Jan 2001

• Pit and Fissure Chemical Curing Sealant

  Class II

  FDA 510(k) K011822 Active Cleared 7 Aug 2001

• Polycarboxylate (Pca) Cement

  Class II

  FDA 510(k) K010240 Active Cleared 27 Mar 2001

• What is the primary purpose of the Enamel Bonding System in dental procedures?

  The Enamel Bonding System is designed to create a durable mechanical and chemical bond between resin restorative materials and tooth enamel. It is specifically used in dental offices to prepare tooth surfaces before applying composite restorations, ensuring stability during the procedure.

• Is the Enamel Bonding System reusable, or is it intended for single-use only?

  The Enamel Bonding System is explicitly supplied as a single-use dental agent. This means each kit is intended for one procedure and should not be reused, helping maintain sterility and performance.

• How is the Enamel Bonding System regulated, and what does that mean for its use?

  The Enamel Bonding System holds an FDA 510(k) clearance (K020050) under regulation 872.3200, classified as substantially equivalent to a predicate device. This means it has undergone review by the FDA to ensure it meets safety and effectiveness standards for its intended use in dental bonding procedures.

• What components does the Enamel Bonding System include, and how does it work?

  The system includes an acid etchant to clean and interlock enamel, followed by the application of a catalyst and base to form a strong bond. The process begins with etching the tooth surface to create micro-retentions, then applying the bonding agent to facilitate adhesion of resin restorations.

• Can the Enamel Bonding System be used in MRI environments, or are there any restrictions?

  The Enamel Bonding System is explicitly not intended for MRI use. This restriction is noted in the device description, so it should not be used in magnetic resonance imaging environments to avoid potential risks or interference.