510(k) · Cleared
ClearedIbond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch Single Dose Assortment, Ibond Self
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Kulzer, LLC · KLE Agent, Tooth Bonding, Resin
Cleared on Dec 7, 2012 as substantially equivalent to K063062 (Heraeus Kulzer, Inc., 2006) after a 46-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Dec 7, 2012
- Review
- 46 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063062 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK063062 Hkbond 2006Heraeus Kulzer, Inc. · 2006
- This deviceK123278 Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value…Heraeus Kulzer, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063062 | Hkbond 2006 | Heraeus Kulzer, Inc. | 2006 | — |
| 0 (this device) | K123278 | Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond… | Heraeus Kulzer, LLC | 2012 | — |
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 |
|---|---|---|---|
| * | K063062 | Hkbond 2006Summary page 1…76 Dental BR2n9iat-ion: 21 CFR 872.3200 Product. code (s:KLE Legally marketed devices(s)l to which -K Bond K063062 H equivalence is claimed: Reason for 5101k) Submtiss I:.. This s… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no 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. 2012, 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?
M~ond Self Etch is an acetone/water-based formulation of light-activated methylacrylate
resins.
M~ond Self Etch is used for bonding of direct light-cured composite restorations
(including Palyglaso and copomers), bonding of indirect restorations in combination with
a light-curing luting cement; porcelain, Polyglas and composite restorations (inlays,
onlays, veneers, crowns) and sealing hypersensitive areas of teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123278 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123278: Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch Single Dose Assortment, Ibond Self.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123278
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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