510(k) · Cleared
ClearedEclipse Bonding Agent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · KLE Agent, Tooth Bonding, Resin
Cleared on Jul 15, 2005 as substantially equivalent to K982007 (Dentsply Intl., 1998) after an 18-day review. Its family tree reaches back 2 generations to 1992. 4 later devices descend from it.
- Decided
- Jul 15, 2005
- Review
- 18 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924422 (1992). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK924422 PalabondHeraeus Kulzer, Inc. · 1992
- 1 generation backK982007 Trubyte Denture Bond Denture Bonding AgentDentsply Intl. · 1998
- This deviceK051707 Eclipse Bonding AgentDentsply Intl. · 2005
- Descendant · cites it directly · 2 of its ownK231578 Lucitone Digital Print Denture SystemDentsply Sirona · 2023
- Descendant · 2 generations on · 0 of its ownK262300 Denture Base Resin V2Formlabs Ohio, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK243336 Lucitone Digital Print Denture™ SystemDentsply Sirona, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK180917 GC Acrylic PrimerGC America, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K231578Lucitone Digital Print Denture SystemDentsply Sirona · 2023 · cites it directly2descendants
- K262300Denture Base Resin V2Formlabs Ohio, Inc. · 2026 · 2 generations on0descendants
- K243336Lucitone Digital Print Denture™ SystemDentsply Sirona, Inc. · 2024 · 2 generations on0descendants
- K180917GC Acrylic PrimerGC America, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924422 | Palabond | Heraeus Kulzer, Inc. | 1992 | — |
| −1 | K982007 | Trubyte Denture Bond Denture Bonding Agent | Dentsply Intl. | 1998 | — |
| 0 (this device) | K051707 | Eclipse Bonding Agent | Dentsply Intl. | 2005 | — |
| +1 | K231578 | Lucitone Digital Print Denture System | Dentsply Sirona | 2023 | — |
| +2 | K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | 2026 | — |
| +2 | K243336 | Lucitone Digital Print Denture™ System | Dentsply Sirona, Inc. | 2024 | — |
| +1 | K180917 | GC Acrylic Primer | GC America, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K982007 | Trubyte Denture Bond Denture Bonding AgentSummary page 1…CATION NAME: Denture relining, repairing, or rebasing resin, 872.3760 PREDICATE DEVICES: Trubyte® Denture Bond Denture Bonding Agent, K(982007 DEVICE DESCRIPTION: and oligomers in a solvent The ECL… | 1998 |
What descends from it? (4)
2 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 13 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231578 (Dentsply Sirona, 2023) has gone furthest, with 2 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?
ECLIPSE® BONDING AGENT is indicated for use in enhancing the bond of acrylic teeth to acrylic removable denture bases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051707 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051707: Eclipse Bonding Agent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051707
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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