# K023042: PQ1

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Oct 28, 2002 after 46 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.
16 later devices descend from it; 2 cite it directly.
0 of 17 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
- K063557: Peak Bond, Model 5133 (2006), 12 descendants of its own
- K100752: Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine) (2010), 7 descendants of its own
- K161051: All-Bond Universal w/BAC (not finalized) (2016), 6 descendants of its own
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own
- K230465: Hi-Bond Universal (2023), 2 descendants of its own

## Indications for use
Use for almost all bonding needs in restorative dentistry. Chemical cure luting and chemical cure composites, namely PerniaFlo DC, also bonds to light cured PQ1. 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/K023042
Methodology: https://510kreport.com/methodology