510(k) · Cleared
ClearedIbond Total Etch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Kulzer,GmbH · KLE Agent, Tooth Bonding, Resin
Cleared on Jan 21, 2009 after a 43-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Jan 21, 2009
- Review
- 43 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK083652 Ibond Total EtchHeraeus Kulzer,GmbH · 2009
- Descendant · cites it directly · 1 of its ownK110403 Prolink Adhesives (Prolink, Prolink SE)Silmet, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK231696 Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew…Prevest Denpro Limited · 2023
- Descendant · cites it directly · 0 of its ownK111431 B1P AdhesivePentron Clinical · 2011
Most influential descendants
Showing 3 of 3 · See all- K110403Prolink Adhesives (Prolink, Prolink SE)Silmet, Ltd. · 2011 · cites it directly1descendant
- K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalPrevest Denpro Limited · 2023 · 2 generations on0descendants
- K111431B1P AdhesivePentron Clinical · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083652 | Ibond Total Etch | Heraeus Kulzer,GmbH | 2009 | — |
| +1 | K110403 | Prolink Adhesives (Prolink, Prolink SE) | Silmet, Ltd. | 2011 | — |
| +2 | K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | Prevest Denpro Limited | 2023 | — |
| +1 | K111431 | B1P Adhesive | Pentron Clinical | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2023 | 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?
The FDA summary names no predicate by number.
What descends from it? (3)
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?
- Of its descendants, K110403 (Silmet, Ltd., 2011) has gone furthest, with 1 descendant 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. 2009, 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?
Bonding of direct composite, Polyglas® and compomer restorations
Bonding of indirect laboratory-fabricated ceramic, Polyglas and composite restorations (inlays, onlays, veneers and crowns)
Treatment of hypersensitive tooth regions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083652 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083652: Ibond Total Etch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083652
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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