510(k) · Cleared
Recalled · Class II · 2022Peak SE, Model 5135
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 14, 2006 as substantially equivalent to K032626 (Ultradent Products, Inc., 2003) and 1 other predicate after a 17-day review. Its family tree reaches back 6 generations to 1993. It has been recalled 2 times.
- Decided
- Dec 14, 2006
- Review
- 17 days
- Class
- Class II
- Product code
- KLE
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 6 generations to K931812 (1993). 17 ancestors in all, the oldest K871636 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 5 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 4 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 3 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 2 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 1 generation backK990040 Clearfil SE BondKuraray Co. · 1999
- This deviceK063558 Peak SE, Model 5135Ultradent Products, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −5 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −4 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −3 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −2 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −1 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| 0 (this device) | K063558 | Peak SE, Model 5135 | Ultradent Products, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 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 |
|---|---|---|---|
| * | K032626 | Permaquick SE Bonding SystemSummary page 1…Classification Product Code: 76KLE Legally Marketed Predicate Devices to which Eqiuivalence is Claimed: 4PermnaQuickTm SE Bonding System K032626 Manufactured and distributed by Ultradent Products, Inc. 505 West 10200 South, South Jordan, Utah 84095.… | 2003 |
| * | K990040 | Clearfil SE BondSummary page 1…g System K032626 Manufactured and distributed by Ultradent Products, Inc. 505 West 10200 South, South Jordan, Utah 84095. Clearfil SE Bond K990040 Manufactured and Distributed by Kuraray America Inc. 101 East 5 2nd Street, 2 6 th Floor New York,… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 1, 2022 | Class II | Z-1368-2022 | Device Design | SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer. |
| May 24, 2012 | Class II | Z-1822-2012 | Labeling mix-ups | Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- None of the 17 ancestors has a recall.
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. Bonds chemical cure luting and
chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate
etching step for quality adhesion. Peak SE is also conducive for bonding to:
o Dentin and enamel
o Porcelain
o Metal
o Composite
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063558 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063558: Peak SE, Model 5135.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063558
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