510(k) · Cleared
ClearedFuture Wash/Yps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe AG Dental Products · ELW Material, Impression
Cleared on Jul 21, 2005 as substantially equivalent to K000588 (Espe Dental AG, 2000) and 1 other predicate after a 16-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Jul 21, 2005
- Review
- 16 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000588 (2000). 2 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000588 Dimension Garant L, Dimension Garant L QuickEspe Dental AG · 2000
- This deviceK051797 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
- Descendant · 3 generations on · 0 of its ownK133400 Flash Bite3M Espe AG · 2014
Most influential descendants
Showing 5 of 5 · See all- 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
- K133400Flash Bite3M Espe AG · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000588 | Dimension Garant L, Dimension Garant L Quick | Espe Dental AG | 2000 | — |
| 0 (this device) | 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 | — |
| +3 | K133400 | Flash Bite | 3M Espe AG | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K000588 | Dimension Garant L, Dimension Garant L QuickSummary page 2…Future Wash Regular Body, Future Wash Regular Body Quick Step: DimensionTM GarantTM L, K000588 YPS Penta HB Quick Step: DimensionTM Pentai M… | 2000 |
| * | K000591 | Dimension Penta H, Dimension Penta H QuickSummary page 2…DimensionTM GarantTM L, K000588 YPS Penta HB Quick Step: DimensionTM Pentai M H, K000591 Description for the Premarket Notification Future Wash and YPS are classified as Im… | 2000 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120438 | Flash (Different Materials) | 2012 | 4 |
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K120438 (3M Deutschland GmbH, 2012) 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 | — |
What is it indicated for?
Future Wash (Future Wash Light Body, Future Wash Light Body Quick Step, Future Wash Regular Body, Future Wash Regular Body Quick Step):
Wash material for all kinds of dual phase impression techniques.
YPS (YPS Penta T HB Quick Step):
Tray material for all kinds of dual phase impression techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051797 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051797: Future Wash/Yps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051797
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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