# K020050: Enamel Bonding System

- Pathway: 510(k) (Traditional)
- Applicant: Rite-Dent Manufacturing Corp.
- Decided: Feb 14, 2002 after 38 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Rite-Dent Bonding System creates a bond between % and all resin restorative materials. It consists of an Acid Etchant, Catalyst Bonding Resin and Base Bonding Resin. The Etchant etches the enamel to increase the surface area for mechanical bonding. The Catalyst and Base infiltrate and mechanically interlock the etched area. After placement of a composite mix on top of the bonded enamel, a chemical bond will form between the composite and the tooth structure.

Source page: https://510kreport.com/device/K020050
Methodology: https://510kreport.com/methodology