510(k) · Cleared
ClearedImpregum Penta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe GmbH & Co. Kg. · ELW Material, Impression
Cleared on Dec 1, 1995 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 1, 1995
- Review
- 86 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK954192 Impregum PentaEspe GmbH & Co. Kg. · 1995
- Descendant · cites it directly · 4 of its ownK992897 Impregum PentaEspe Dental AG · 1999
- Descendant · 2 generations on · 3 of its ownK994192 Impregum Penta M MonosoftEspe Dental AG · 2000
- Descendant · 3 generations on · 2 of its ownK032001 Poly Q (Garant L, Penta M, Penta H)3M Espe AG Dental Products · 2003
- Descendant · 4 generations on · 0 of its ownK173318 Rapid HB, Rapid LB, Rapid MB3M Deutschland GmbH · 2017
- Descendant · 3 generations on · 0 of its ownK080514 Pecd-01 and Pecd Quick-013M Espe AG Dental Products · 2008
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K992897Impregum PentaEspe Dental AG · 1999 · cites it directly4descendants
- K994192Impregum Penta M MonosoftEspe Dental AG · 2000 · 2 generations on3descendants
- K032001Poly Q (Garant L, Penta M, Penta H)3M Espe AG Dental Products · 2003 · 3 generations on2descendants
- K173318Rapid HB, Rapid LB, Rapid MB3M Deutschland GmbH · 2017 · 4 generations on0descendants
- K080514Pecd-01 and Pecd Quick-013M Espe AG Dental Products · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954192 | Impregum Penta | Espe GmbH & Co. Kg. | 1995 | — |
| +1 | K992897 | Impregum Penta | Espe Dental AG | 1999 | — |
| +2 | K994192 | Impregum Penta M Monosoft | Espe Dental AG | 2000 | — |
| +3 | K032001 | Poly Q (Garant L, Penta M, Penta H) | 3M Espe AG Dental Products | 2003 | — |
| +4 | K173318 | Rapid HB, Rapid LB, Rapid MB | 3M Deutschland GmbH | 2017 | — |
| +3 | K080514 | Pecd-01 and Pecd Quick-01 | 3M Espe AG Dental Products | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 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 ELW? 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 ELW device
- #1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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, K992897 (Espe Dental AG, 1999) has gone furthest, with 4 descendants of its own.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELW
98in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELW
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELW
22in 2025
MAUDE reports naming product code ELW, 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 | 7 | 60 | 0 | 9 |
| 2008 | 11 | 30 | 0 | 17 |
| 2009 | 7 | 43 | 0 | 7 |
| 2010 | 5 | 88 | 1 | 16 |
| 2011 | 9 | 83 | 0 | 15 |
| 2012 | 7 | 87 | 1 | 14 |
| 2013 | 5 | 67 | 3 | 32 |
| 2014 | 11 | 122 | 0 | 35 |
| 2015 | 8 | 93 | 0 | 18 |
| 2016 | 7 | 166 | 3 | 15 |
| 2017 | 3 | 89 | 0 | 17 |
| 2018 | 5 | 126 | 0 | 14 |
| 2019 | 2 | — | 0 | 24 |
| 2020 | 4 | 99 | 0 | 8 |
| 2021 | 3 | 76 | 0 | 6 |
| 2022 | 7 | 60 | 0 | 9 |
| 2023 | 2 | — | 0 | 13 |
| 2024 | 3 | 98 | 0 | 3 |
| 2025 | 2 | — | 0 | 22 |
| 2026 | 3 | 268 | 0 | — |
https://510kreport.com/device/K954192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954192: Impregum Penta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954192
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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