# K974906: One Coat Bond Dentin/Enamel Adhesive System

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent, Inc.
- Decided: Mar 24, 1998 after 83 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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.

## Most influential descendants
- K992879: Ecusit Composite Repair (1999), 2 descendants of its own
- K041960: Composite/Compomer Repair Kit (2004), 1 descendant of its own
- K063444: Total Etch Bonding Agent (2007), 0 descendants of its own

## Indications for use
Bonding adhesive restoration techniques. Direct filling technique: * Adhesive bonding of composite materials to natural enamel and dentine (colténe® SYNERGY, colténe® Brilliant Dentin/ Enamel/Incisal). Indirect restorative techniques: Adhesive bonding of ceramic and composite patterns with colténe® Duo Cement to natural enamel and dentine. Adhesive bonding of other dental materials: * composite materials to pretreated ceramics * composite material to composite material * composite material to pretreated metals * dentine sealing Sclerotic dentin: * Use 35 % phosphoric acid for 30 s (e.g. colténe® Etchant Gel S)

Source page: https://510kreport.com/device/K974906
Methodology: https://510kreport.com/methodology