510(k) · Cleared
Recalled · Class II · 2013Dimension Penta H, Dimension Penta H Quick
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 Mar 30, 2000 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled once.
- Decided
- Mar 30, 2000
- Review
- 37 days
- Class
- Class II
- Product code
- ELW
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK000591 Dimension Penta H, Dimension Penta H QuickEspe Dental AG · 2000
- Descendant · cites it directly · 5 of its ownK051797 Future Wash/Yps3M Espe AG Dental Products · 2005
- Descendant · cites it directly · 4 of its ownK120438 Flash (Different Materials)3M Deutschland GmbH · 2012
- Descendant · 2 generations on · 2 of its ownK131404 Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013
- Descendant · 2 generations on · 0 of its ownK140602 Flash Penta MB Quick, Flash MB Quick3M Espe AG · 2014
- Descendant · 3 generations on · 0 of its ownK133436 Flash AR; Flash AR Quick3M Deutschland GmbH · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K051797Future Wash/Yps3M Espe AG Dental Products · 2005 · cites it directly5descendants
- K120438Flash (Different Materials)3M Deutschland GmbH · 2012 · cites it directly4descendants
- K131404Flash AR Penta / Flash AR Penta Quick3M Deutschland GmbH · 2013 · 2 generations on2descendants
- K140602Flash Penta MB Quick, Flash MB Quick3M Espe AG · 2014 · 2 generations on0descendants
- K133436Flash AR; Flash AR Quick3M Deutschland GmbH · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000591 | Dimension Penta H, Dimension Penta H Quick | Espe Dental AG | 2000 | — |
| +1 | K051797 | Future Wash/Yps | 3M Espe AG Dental Products | 2005 | — |
| +1 | K120438 | Flash (Different Materials) | 3M Deutschland GmbH | 2012 | — |
| +2 | K131404 | Flash AR Penta / Flash AR Penta Quick | 3M Deutschland GmbH | 2013 | — |
| +2 | K140602 | Flash Penta MB Quick, Flash MB Quick | 3M Espe AG | 2014 | — |
| +3 | K133436 | Flash AR; Flash AR Quick | 3M Deutschland GmbH | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2013 | Class II | Z-0535-2014 | Employee error | Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051797 (3M Espe AG Dental Products, 2005) has gone furthest, with 5 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/K000591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000591: Dimension Penta H, Dimension Penta H Quick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000591
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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