# K033760: One Coat SE Bond

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent, Inc.
- Decided: Jan 23, 2004 after 52 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K072480: Generation 8 SE Adhesive (2007), 0 descendants of its own

## Indications for use
One Coat SE Bond, a self etching dental adhesive, is indicated for the following: · The bonding of indirect restorations (inlays, onlays, veneers, when used with lightcure or dual cure luting cements) to tooth structure. · The bonding of direct fillings of composite or compomer. · The bonding of composite to amalgam. · The repairing of metal/ceramic, ceramic or composite restorations. * The sealing of sensitive teeth.

Source page: https://510kreport.com/device/K033760
Methodology: https://510kreport.com/methodology