510(k) · Cleared
ClearedAquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · ELW Material, Impression
Cleared on May 13, 2002 as substantially equivalent to K943574 (Dentsply Intl., 1994) after a 10-day review. Its family tree reaches back 1 generation to 1994. 46 later devices descend from it.
- Decided
- May 13, 2002
- Review
- 10 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943574 (1994). 46 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK943574 Capture Impression MaterialDentsply Intl. · 1994
- This deviceK021416 Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialDentsply Intl. · 2002
- Descendant · cites it directly · 25 of its ownK040053 Precision VPS Impression MaterialDiscus Dental, Inc. · 2004
- Descendant · 2 generations on · 14 of its ownK062450 D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2006
- Descendant · cites it directly · 13 of its ownK103164 Vonflex Heavy, Vinflex LightVericom Co., Ltd. · 2010
- Descendant · 2 generations on · 12 of its ownK152766 CharmFlexDentkist, Inc. · 2016
- Descendant · 3 generations on · 10 of its ownK170736 HySil Impression MaterialsOsstem Implant Co., Ltd. · 2017
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K040053Precision VPS Impression MaterialDiscus Dental, Inc. · 2004 · cites it directly25descendants
- K062450D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd. · 2006 · 2 generations on14descendants
- K103164Vonflex Heavy, Vinflex LightVericom Co., Ltd. · 2010 · cites it directly13descendants
- K152766CharmFlexDentkist, Inc. · 2016 · 2 generations on12descendants
- K170736HySil Impression MaterialsOsstem Implant Co., Ltd. · 2017 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| 0 (this device) | K021416 | Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| +1 | K040053 | Precision VPS Impression Material | Discus Dental, Inc. | 2004 | — |
| +2 | K062450 | D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | 2006 | — |
| +1 | K103164 | Vonflex Heavy, Vinflex Light | Vericom Co., Ltd. | 2010 | — |
| +2 | K152766 | CharmFlex | Dentkist, Inc. | 2016 | — |
| +3 | K170736 | HySil Impression Materials | Osstem Implant Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 6 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K943574 | Capture Impression MaterialSummary page 1…low viscosity material. Use Fast Set for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques. SPECIAL 510() MODIFICATION TO K943574 69 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service " Food and Drug Administration - 9200 Corporate B… | 1994 |
What descends from it? (46)
See all 464 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?
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?
Used as impression materials in a dual phase impression technique. They may also be used for precise duplication of models. Use Regular Set for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs a monophase, heavy, or low viscosity material. Use Fast Set for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.
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/K021416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021416: Aquasil Ultra Monophase/Heavy/LV 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/K021416
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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