# K974283: PQ 1

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Jan 29, 1998 after 76 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
PQ 1 PermaQuick Bonding System is used for 95% of bonding needs in restorative dentistry. Ease of use and unsurpassed bond strength makes PQ 1 the agent of choice for all light cure bonding needs. PQ 1 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/K974283
Methodology: https://510kreport.com/methodology