510(k) · Cleared
ClearedModified Permagum Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe GmbH (Us) · EBH Material, Impression Tray, Resin
Cleared on Jul 27, 1988 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Jul 27, 1988
- Review
- 86 days
- Class
- Class I
- Product code
- EBH
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK881838 Modified Permagum AdhesiveEspe GmbH (Us) · 1988
- Descendant · cites it directly · 11 of its ownK960547 Dimension Penta/Dimension Garant L/Polyvinyl Siloxane AdhesiveEspe GmbH & Co. Kg. · 1996
- Descendant · 2 generations on · 8 of its ownK974231 Position Penta, Position Penta QuickEspe GmbH & Co. Kg. · 1998
- Descendant · 3 generations on · 2 of its ownK131404 Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013
- Descendant · 3 generations on · 1 of its ownK090718 Bellus Shading Kit3M Espe AG Dental Products · 2009
- Descendant · 2 generations on · 1 of its ownK991008 Dimension BiteEspe Dental AG · 1999
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K960547Dimension Penta/Dimension Garant L/Polyvinyl Siloxane AdhesiveEspe GmbH & Co. Kg. · 1996 · cites it directly11descendants
- K974231Position Penta, Position Penta QuickEspe GmbH & Co. Kg. · 1998 · 2 generations on8descendants
- K131404Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013 · 3 generations on2descendants
- K090718Bellus Shading Kit3M Espe AG Dental Products · 2009 · 3 generations on1descendant
- K991008Dimension BiteEspe Dental AG · 1999 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K881838 | Modified Permagum Adhesive | Espe GmbH (Us) | 1988 | — |
| +1 | K960547 | Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive | Espe GmbH & Co. Kg. | 1996 | — |
| +2 | K974231 | Position Penta, Position Penta Quick | Espe GmbH & Co. Kg. | 1998 | — |
| +3 | K131404 | Flash AR Penta / Flash AR Penta Quick | 3M Deutschland GmbH | 2013 | — |
| +3 | K090718 | Bellus Shading Kit | 3M Espe AG Dental Products | 2009 | — |
| +2 | K991008 | Dimension Bite | Espe Dental AG | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 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 EBH? 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? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K960547 | Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive | 1996 | 11 |
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, K960547 (Espe GmbH & Co. Kg., 1996) has gone furthest, with 11 descendants of its own.
How does its category compare?
All EBH devicesEBH Material, Impression Tray, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBH
FDA has decided no EBH device since 2007.
Median 510(k) review, days · EBH
Too few EBH 510(k)s in any year since 2007 to give a median.
Recalls per year · EBH
No recall names EBH since 2007.
Adverse event reports per year · EBH
1in 2013
MAUDE reports naming product code EBH, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 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/K881838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K881838: Modified Permagum Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881838
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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