# K032626: Permaquick SE Bonding System

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Dec 3, 2003 after 99 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
- K063558: Peak SE, Model 5135 (2006), 0 descendants of its own

## Indications for use
Use for almost all bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC, also bonds to light cured PermaQuick SE. PermaQuick SE does not require a separate etching step for quality adhesion. PermaQuick SE is conducive for bonding to: 1. Dentin and Enamel using composite or amalgam 2. Porcelain 3. Metal 4. Composite repair

Source page: https://510kreport.com/device/K032626
Methodology: https://510kreport.com/methodology