510(k) · Cleared
ClearedVitrabond Light Cure Glass Ionomer Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · EKJ Burnisher, Operative
Cleared on Sep 15, 1988 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Sep 15, 1988
- Review
- 69 days
- Class
- Class I
- Product code
- EKJ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK882821 Vitrabond Light Cure Glass Ionomer Liner3M Company · 1988
- Descendant · cites it directly · 1 of its ownK962065 3M Vitrebond Light Cure Glass Ionomer/Base3M Company · 1996
- Descendant · cites it directly · 0 of its ownK991172 Ionosit BondDmg Chemisch Pharmazeutische Fabrik GmbH · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K882821 | Vitrabond Light Cure Glass Ionomer Liner | 3M Company | 1988 | — |
| +1 | K962065 | 3M Vitrebond Light Cure Glass Ionomer/Base | 3M Company | 1996 | — |
| +1 | K991172 | Ionosit Bond | Dmg Chemisch Pharmazeutische Fabrik GmbH | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 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 EKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
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, K962065 (3M Company, 1996) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EKJ devicesEKJ Burnisher, Operative: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EKJ
FDA has decided no EKJ device since 2007.
Median 510(k) review, days · EKJ
Too few EKJ 510(k)s in any year since 2007 to give a median.
Recalls per year · EKJ
No recall names EKJ since 2007.
Adverse event reports per year · EKJ
2in 2015
MAUDE reports naming product code EKJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K882821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K882821: Vitrabond Light Cure Glass Ionomer Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882821
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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