510(k) · Cleared
ClearedAquasil Ultra Smart Wetting Impression Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International, Inc. · ELW Material, Impression
Cleared on Feb 13, 2012 as substantially equivalent to K021410 (Dentsply Intl., 2002) and 2 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it.
- Decided
- Feb 13, 2012
- Review
- 87 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K943574 (1994). 6 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 2 generations backK973782 Aquasil XLV Smart Wetting Impression MaterialDentsply Intl. · 1997
- 1 generation backK021410 Aquasil Ultra XLV Smart Wetting Impression MaterialDentsply Intl. · 2002
- This deviceK113406 Aquasil Ultra Smart Wetting Impression MaterialDentsply International, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK152615 Vonflex SVericom Co., Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK152861 Aquasil Ultra + Smart Wetting Impression MaterialDentply International, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK220097 PRESIDENT The OriginalColtène/Whaledent AG · 2022
- Descendant · 3 generations on · 0 of its ownK242360 Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty…Dent4you AG · 2024
- Descendant · 2 generations on · 0 of its ownK233954 Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluB&E Korea Co., Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K152615Vonflex SVericom Co., Ltd. · 2016 · cites it directly2descendants
- K152861Aquasil Ultra + Smart Wetting Impression MaterialDentply International, Inc. · 2016 · cites it directly2descendants
- K220097PRESIDENT The OriginalColtène/Whaledent AG · 2022 · 2 generations on1descendant
- K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal…Dent4you AG · 2024 · 3 generations on0descendants
- K233954Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluB&E Korea Co., Ltd. · 2024 · 2 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 | K973782 | Aquasil XLV Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| −1 | K021410 | Aquasil Ultra XLV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| 0 (this device) | K113406 | Aquasil Ultra Smart Wetting Impression Material | Dentsply International, Inc. | 2012 | — |
| +1 | K152615 | Vonflex S | Vericom Co., Ltd. | 2016 | — |
| +1 | K152861 | Aquasil Ultra + Smart Wetting Impression Material | Dentply International, Inc. | 2016 | — |
| +2 | K220097 | PRESIDENT The Original | Coltène/Whaledent AG | 2022 | — |
| +3 | K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex… | Dent4you AG | 2024 | — |
| +2 | K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | B&E Korea Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K021410 | Aquasil Ultra XLV Smart Wetting Impression MaterialSummary page 1…1I " Product Code: - ELW 3. Predicate Device: DENTSPLY International's: * K02 1410- Aquasil Ultra XLV Smart Wetting Impression Material- * K02 1413- Aquasil Ultra Rigid Smart Wetting Impression Materia… | 2002 |
| * | K021413 | Aquasil Ultra Rigid Smart Wetting Impression MaterialSummary page 1…- ELW 3. Predicate Device: DENTSPLY International's: * K02 1410- Aquasil Ultra XLV Smart Wetting Impression Material- * K02 1413- Aquasil Ultra Rigid Smart Wetting Impression Material * K021416- Aquasil Ultra Monophase, Heavy and LV Smart Wetting… | 2002 |
| * | K021416 | Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialSummary page 1…'s: * K02 1410- Aquasil Ultra XLV Smart Wetting Impression Material- * K02 1413- Aquasil Ultra Rigid Smart Wetting Impression Material * K021416- Aquasil Ultra Monophase, Heavy and LV Smart Wetting Impression Material. 4. Description of Device:… | 2002 |
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?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K152615 (Vericom Co., Ltd., 2016) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K021410.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL is indicated for all dental impression techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113406: Aquasil Ultra Smart Wetting Impression Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113406
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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