510(k) · Cleared
ClearedSurpass
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex Dental Materials, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Jul 31, 2006 as substantially equivalent to K945604 (Bisco, Inc., 1995) and 1 other predicate after an 18-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Jul 31, 2006
- Review
- 18 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945604 (1995). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K093019Enamelite Acryseal Spray SealantEnamelite, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945604 | Ecliptomer | Bisco, Inc. | 1995 | — |
| −1 | K020570 | Simplicity | Apex Dental Materials, Inc. | 2002 | — |
| 0 (this device) | K061981 | Surpass | Apex Dental Materials, Inc. | 2006 | — |
| +1 | K093019 | Enamelite Acryseal Spray Sealant | Enamelite, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K945604 | EcliptomerSummary page 1…: Regulatory Class: IL Product Code: KLE IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE PREDICATE DEVICE ECLIPTOMER (510OK number K945604, Bisco, Inc.) is a universal dental adhesive system that is designed to bond composite to dentin, enamel, cast metals, treated p… | 1995 |
| * | K020570 | SimplicitySummary page 3…ntly marketed in the United States (see Confidential Formulation Details on page 5). In addition, SURPASSTM is essentially our Simplicity® Adhesive System (510K: K020570) with an added bonding resin (SURPASSTM 3). SURPASSTM has the same indication for use and same base composition as the Simplicit… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093019 | Enamelite Acryseal Spray Sealant | 2009 | 0 |
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 11 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K093019 (Enamelite, LLC, 2009) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K945604.
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?
* Restorations: to seal enamel/dentin prior to restoring with light-cured or self-cured composite materials.
* Indirect Restorations: to seal a preparation when using a light-cured, self-cured or dual-cured composite cement or glass ionomer or resin-modified glass ionomer cement.
* Desensitization: to treat hypersensitive and/or exposed root surfaces.
* To bond in a post and core
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061981 · printed Nov 3, 2026
Cite this page
510(k) Report. “K061981: Surpass.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K061981
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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