510(k) · Cleared
ClearedSplash! Impression Material Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Discus Dental, Inc. · ELW Material, Impression
Cleared on Aug 5, 2005 as substantially equivalent to K040053 (Discus Dental, Inc., 2004) and 2 other predicates after a 3-day review. Its family tree reaches back 3 generations to 1994. 7 later devices descend from it.
- Decided
- Aug 5, 2005
- Review
- 3 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K943574 (1994). 4 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 2 generations backK021416 Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 1 generation backK040053 Precision VPS Impression MaterialDiscus Dental, Inc. · 2004
- This deviceK052090 Splash! Impression Material DeviceDiscus Dental, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK053427 Fresh, Dental Impression MaterialExacta Dental Products, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK171562 Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax monoDreve Dentamid GmbH · 2018
- Descendant · 3 generations on · 3 of its ownK213244 Accusil Dental Impression Materials (Accusil Light Body Regular and…Prevest Denpro Limited · 2022
- Descendant · 4 generations on · 1 of its ownK251724 Remi Impression MaterialGrindguard, Inc. · 2026
- Descendant · 5 generations on · 0 of its ownK261888 ClearClub Impression MaterialClearClub · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K053427Fresh, Dental Impression MaterialExacta Dental Products, Inc. · 2006 · cites it directly5descendants
- K171562Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax monoDreve Dentamid GmbH · 2018 · 2 generations on4descendants
- K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil…Prevest Denpro Limited · 2022 · 3 generations on3descendants
- K251724Remi Impression MaterialGrindguard, Inc. · 2026 · 4 generations on1descendant
- K261888ClearClub Impression MaterialClearClub · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −2 | K021416 | Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −1 | K040053 | Precision VPS Impression Material | Discus Dental, Inc. | 2004 | — |
| 0 (this device) | K052090 | Splash! Impression Material Device | Discus Dental, Inc. | 2005 | — |
| +1 | K053427 | Fresh, Dental Impression Material | Exacta Dental Products, Inc. | 2006 | — |
| +2 | K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono | Dreve Dentamid GmbH | 2018 | — |
| +3 | K213244 | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set… | Prevest Denpro Limited | 2022 | — |
| +4 | K251724 | Remi Impression Material | Grindguard, Inc. | 2026 | — |
| +5 | K261888 | ClearClub Impression Material | ClearClub | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K040053 | Precision VPS Impression MaterialSummary page 2…Company 510(k) No. (Primary) Precision VPS Impression Discus Dental K040053 Material Predicate Device Company 510(k) No.… | 2004 |
| * | K030318 | P2 PolyetherSummary page 2…Company 510(k) No. (Secondary) P2 Polyether Heraeus Kulzer Inc K030318 Aquasil Smart Wetting Denstply, Intl. K021416 Impression Materia… | 2003 |
| * | K021416 | Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialSummary page 2…Heraeus Kulzer Inc K030318 Aquasil Smart Wetting Denstply, Intl. K021416 Impression Material Predicate Similarities Product Company… | 2002 |
What descends from it? (7)
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 11 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K053427 (Exacta Dental Products, Inc., 2006) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K040053.
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?
Splash!® Dental Impression Material is intended for use with all crowns, bridges,
occlusal and dental implant impression techniques to reproduce the structure of a
patient's teeth and gums,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052090: Splash! Impression Material Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052090
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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