510(k) · Cleared
ClearedEcliptomer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bisco, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Jan 3, 1995 after a 49-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 3, 1995
- Review
- 49 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK945604 EcliptomerBisco, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK020570 SimplicityApex Dental Materials, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK061981 SurpassApex Dental Materials, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK120767 ES BondSpident Co., Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK093019 Enamelite Acryseal Spray SealantEnamelite, LLC · 2009
- Descendant · cites it directly · 0 of its ownK992838 Adhere Conditioner, Adhere Primer, Adhere LC Adhesive, Adhere DC…Biomat Sciences, Inc. · 1999
Most influential descendants
Showing 5 of 5 · See all- K020570SimplicityApex Dental Materials, Inc. · 2002 · cites it directly2descendants
- K061981SurpassApex Dental Materials, Inc. · 2006 · cites it directly1descendant
- K120767ES BondSpident Co., Ltd. · 2012 · cites it directly0descendants
- K093019Enamelite Acryseal Spray SealantEnamelite, LLC · 2009 · 2 generations on0descendants
- K992838Adhere Conditioner, Adhere Primer, Adhere LC Adhesive, Adhere DC Adhere DC Activator…Biomat Sciences, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945604 | Ecliptomer | Bisco, Inc. | 1995 | — |
| +1 | K020570 | Simplicity | Apex Dental Materials, Inc. | 2002 | — |
| +1 | K061981 | Surpass | Apex Dental Materials, Inc. | 2006 | — |
| +1 | K120767 | ES Bond | Spident Co., Ltd. | 2012 | — |
| +2 | K093019 | Enamelite Acryseal Spray Sealant | Enamelite, LLC | 2009 | — |
| +1 | K992838 | Adhere Conditioner, Adhere Primer, Adhere LC Adhesive, Adhere DC Adhere DC… | Biomat Sciences, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
4 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?
- Of its descendants, K020570 (Apex Dental Materials, Inc., 2002) 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 | — |
https://510kreport.com/device/K945604 · printed Nov 4, 2026
Cite this page
510(k) Report. “K945604: Ecliptomer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945604
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026