# K983668: Modification of PQ1

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Nov 30, 1998 after 42 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
Use for almost all bonding needs in restorative dentistry. Ease of use and unsurpassed bond strength in a single syringe primer/bonding resin makes PQ1 the agent of choice for most light cure bonding needs. Also use PQ1 with chemical cure luting and chemical cure composite (e.g. Permalute). PQ1 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/K983668
Methodology: https://510kreport.com/methodology