510(k) · Cleared
ClearedPeak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine)
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 Jul 16, 2010 as substantially equivalent to K063557 (Ultradent Products, Inc., 2006) and 1 other predicate after a 121-day review. Its family tree reaches back 2 generations to 2002. 7 later devices descend from it.
- Decided
- Jul 16, 2010
- Review
- 121 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K023042 (2002). 3 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK023042 PQ1Ultradent Products, Inc. · 2002
- 1 generation backK063557 Peak Bond, Model 5133Ultradent Products, Inc. · 2006
- This deviceK100752 Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine)Ultradent Products, Inc. · 2010
- Descendant · cites it directly · 6 of its ownK161051 All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK230465 Hi-Bond UniversalMediclus Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK240743 Peak Universal BondUltradent Products, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK213401 DIAPLUS UniversalDiaDent Group International · 2022
- Descendant · cites it directly · 0 of its ownK262252 MPa Max adhesiveDen-Mat Holdings, LLC · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016 · cites it directly6descendants
- K230465Hi-Bond UniversalMediclus Co., Ltd. · 2023 · 2 generations on2descendants
- K240743Peak Universal BondUltradent Products, Inc. · 2024 · cites it directly1descendant
- K213401DIAPLUS UniversalDiaDent Group International · 2022 · 2 generations on1descendant
- K262252MPa Max adhesiveDen-Mat Holdings, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023042 | PQ1 | Ultradent Products, Inc. | 2002 | — |
| −1 | K063557 | Peak Bond, Model 5133 | Ultradent Products, Inc. | 2006 | — |
| 0 (this device) | K100752 | Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine) | Ultradent Products, Inc. | 2010 | — |
| +1 | K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016 | — |
| +2 | K230465 | Hi-Bond Universal | Mediclus Co., Ltd. | 2023 | — |
| +1 | K240743 | Peak Universal Bond | Ultradent Products, Inc. | 2024 | — |
| +2 | K213401 | DIAPLUS Universal | DiaDent Group International | 2022 | — |
| +1 | K262252 | MPa Max adhesive | Den-Mat Holdings, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K063557 | Peak Bond, Model 5133Summary page 4…ditional 510(k) is to inform the FDA of our intent to market a new product, Peak"M Universal Bond. This product can be used for dental patients of all ages. Peak'" Bond (K063557) and Premier NexTemp (K051866) are our predicates. The formula has been modified as follows: Add 0.2 Chlorhexidline Dia… | 2006 |
| * | K051866 | Premier Temporary CementSummary page 4…he FDA of our intent to market a new product, Peak"M Universal Bond. This product can be used for dental patients of all ages. Peak'" Bond (K063557) and Premier NexTemp (K051866) are our predicates. The formula has been modified as follows: Add 0.2 Chlorhexidline Diacetate Our goal is to releas… | 2005 |
What descends from it? (7)
3 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?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 4.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K161051 (Bisco, Inc., 2016) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K063557.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 virtually all etching and bonding needs in restorative dentistry for patients of all ages.
Peak Universal Bond bonds to the following materials:
* Dentin and enamel
* Porcelain
* Metal
* Composite
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100752 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100752: Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100752
Report an extraction error
Are you the manufacturer?
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