510(k) · Cleared
ClearedPeak Bond, Model 5133
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 Dec 12, 2006 as substantially equivalent to K023042 (Ultradent Products, Inc., 2002) after a 15-day review. Its family tree reaches back 1 generation to 2002. 12 later devices descend from it.
- Decided
- Dec 12, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023042 (2002). 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK023042 PQ1Ultradent Products, Inc. · 2002
- This deviceK063557 Peak Bond, Model 5133Ultradent Products, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK100752 Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine)Ultradent Products, Inc. · 2010
- Descendant · 2 generations on · 6 of its ownK161051 All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK081913 Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008
- Descendant · 3 generations on · 2 of its ownK230465 Hi-Bond UniversalMediclus Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK240743 Peak Universal BondUltradent Products, Inc. · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K100752Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine)Ultradent Products, Inc. · 2010 · cites it directly7descendants
- K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016 · 2 generations on6descendants
- K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008 · cites it directly3descendants
- K230465Hi-Bond UniversalMediclus Co., Ltd. · 2023 · 3 generations on2descendants
- K240743Peak Universal BondUltradent Products, Inc. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023042 | PQ1 | Ultradent Products, Inc. | 2002 | — |
| 0 (this device) | K063557 | Peak Bond, Model 5133 | Ultradent Products, Inc. | 2006 | — |
| +1 | K100752 | Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine) | Ultradent Products, Inc. | 2010 | — |
| +2 | K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016 | — |
| +1 | K081913 | Metacem, Meta P&Bond, Metacem Silane Ceramic Primer | Meta Biomed Co., Ltd. | 2008 | — |
| +3 | K230465 | Hi-Bond Universal | Mediclus Co., Ltd. | 2023 | — |
| +2 | K240743 | Peak Universal Bond | Ultradent Products, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023042 | PQ1Summary page 1…ion Product Code: 76KLE Legally Marketed Predicate Devices to which Eqiuivalence is Claimed: Predicate: PQI®/ Ultradent Products, Inc. /K023042 Manufactured and distributed by Ultradent Products, Inc. 505 West 10200 South, South Jordan, Utah 84095. 505 We… | 2002 |
What descends from it? (12)
See all 122 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?
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 most bonding needs in restorative dentistry. PeakTM Bond is formulated to work well with flowable composite for light cure luting. Ultradent recommends the PermaFlow® DC system using chemical cure PermaFlow® DC primer for chemical cure/dual core bonding (e.g., non-translucent veners, inlays, and post bonding).
Peak MT Bond bonds to the following materials:
o Dentin and enamel
o Porcelain
o Metal
o Composite
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063557 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063557: Peak Bond, Model 5133.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063557
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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