510(k) · Cleared
ClearedPQ1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultradent Products, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Oct 28, 2002 after a 46-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 16 later devices descend from it.
- Decided
- Oct 28, 2002
- Review
- 46 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK023042 PQ1Ultradent Products, Inc. · 2002
- Descendant · cites it directly · 12 of its ownK063557 Peak Bond, Model 5133Ultradent Products, Inc. · 2006
- Descendant · 2 generations on · 7 of its ownK100752 Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine)Ultradent Products, Inc. · 2010
- Descendant · 3 generations on · 6 of its ownK161051 All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK081913 Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008
- Descendant · 4 generations on · 2 of its ownK230465 Hi-Bond UniversalMediclus Co., Ltd. · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K063557Peak Bond, Model 5133Ultradent Products, Inc. · 2006 · cites it directly12descendants
- K100752Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine)Ultradent Products, Inc. · 2010 · 2 generations on7descendants
- K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016 · 3 generations on6descendants
- K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008 · 2 generations on3descendants
- K230465Hi-Bond UniversalMediclus Co., Ltd. · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023042 | PQ1 | Ultradent Products, Inc. | 2002 | — |
| +1 | K063557 | Peak Bond, Model 5133 | Ultradent Products, Inc. | 2006 | — |
| +2 | K100752 | Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine) | Ultradent Products, Inc. | 2010 | — |
| +3 | K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016 | — |
| +2 | K081913 | Metacem, Meta P&Bond, Metacem Silane Ceramic Primer | Meta Biomed Co., Ltd. | 2008 | — |
| +4 | K230465 | Hi-Bond Universal | Mediclus Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KLE device
- #1 K262252 MPa Max adhesivescore 15.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K063557 (Ultradent Products, Inc., 2006) has gone furthest, with 12 descendants of its own.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLE
149in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLE
3in 2025
MAUDE reports naming product code KLE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 71 | 2 | 18 |
| 2008 | 3 | 66 | 0 | 9 |
| 2009 | 7 | 79 | 1 | 11 |
| 2010 | 8 | 93 | 1 | 13 |
| 2011 | 10 | 100 | 0 | 69 |
| 2012 | 5 | 66 | 0 | 176 |
| 2013 | 11 | 115 | 0 | 248 |
| 2014 | 6 | 120 | 0 | 260 |
| 2015 | 10 | 118 | 0 | 100 |
| 2016 | 3 | 148 | 1 | 47 |
| 2017 | 4 | 171 | 1 | 42 |
| 2018 | 8 | 124 | 0 | 31 |
| 2019 | 6 | 143 | 0 | 20 |
| 2020 | 6 | 195 | 0 | 6 |
| 2021 | 4 | 163 | 0 | 6 |
| 2022 | 8 | 98 | 0 | 7 |
| 2023 | 6 | 75 | 0 | 7 |
| 2024 | 7 | 61 | 1 | 12 |
| 2025 | 3 | 149 | 0 | 3 |
| 2026 | 7 | 84 | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023042 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023042: PQ1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023042
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026