510(k) · Cleared
ClearedImpregum Penta M Monosoft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe Dental AG · ELW Material, Impression
Cleared on Jan 28, 2000 as substantially equivalent to K992897 (Espe Dental AG, 1999) after a 46-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Jan 28, 2000
- Review
- 46 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954192 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK954192 Impregum PentaEspe GmbH & Co. Kg. · 1995
- 1 generation backK992897 Impregum PentaEspe Dental AG · 1999
- This deviceK994192 Impregum Penta M MonosoftEspe Dental AG · 2000
- Descendant · cites it directly · 2 of its ownK032001 Poly Q (Garant L, Penta M, Penta H)3M Espe AG Dental Products · 2003
- Descendant · 2 generations on · 0 of its ownK173318 Rapid HB, Rapid LB, Rapid MB3M Deutschland GmbH · 2017
- Descendant · cites it directly · 0 of its ownK080514 Pecd-01 and Pecd Quick-013M Espe AG Dental Products · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954192 | Impregum Penta | Espe GmbH & Co. Kg. | 1995 | — |
| −1 | K992897 | Impregum Penta | Espe Dental AG | 1999 | — |
| 0 (this device) | K994192 | Impregum Penta M Monosoft | Espe Dental AG | 2000 | — |
| +1 | K032001 | Poly Q (Garant L, Penta M, Penta H) | 3M Espe AG Dental Products | 2003 | — |
| +2 | K173318 | Rapid HB, Rapid LB, Rapid MB | 3M Deutschland GmbH | 2017 | — |
| +1 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 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 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? (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 |
|---|---|---|---|
| * | K992897 | Impregum PentaSummary page 1…..........cccccvvevveenenee Impression material Common Name:..........cccovveereeereeecnnnns Polyether based impression material Predicate Device IMPREGUM® PENTA® ..., K 992897 Description for the Premarket Notification IMPREGUM® PENTA® M MONOSOFT is classified as an impression material (21 C.F.R. § 872… | 1999 |
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K032001 (3M Espe AG Dental Products, 2003) has gone furthest, with 2 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 | — |
What is it indicated for?
Dental impression material for automatic mixing and dispensing in a PENTAMIX® or PENTAMiX® 2 mixing device, resp.:
Impressions for inlay, onlay, crown, and bridge restorations
Functional impressions
Fixation impressions
Implant impressions
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994192: Impregum Penta M Monosoft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994192
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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