510(k) · Cleared
ClearedCapture 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 Aug 23, 1994 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 60 later devices descend from it.
- Decided
- Aug 23, 1994
- Review
- 32 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 0
60 later devices descend from it, 4 citing it directly.
- This deviceK943574 Capture Impression MaterialDentsply Intl. · 1994
- Descendant · cites it directly · 46 of its ownK021416 Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialDentsply Intl. · 2002
- Descendant · cites it directly · 28 of its ownK970433 Aquasil Rigid Smart Wetting Impression MaterialDentsply Intl. · 1997
- Descendant · 2 generations on · 27 of its ownK021413 Aquasil Ultra Rigid Smart Wetting Impression MaterialDentsply Intl. · 2002
- Descendant · 2 generations on · 25 of its ownK040053 Precision VPS Impression MaterialDiscus Dental, Inc. · 2004
- Descendant · cites it directly · 25 of its ownK973782 Aquasil XLV Smart Wetting Impression MaterialDentsply Intl. · 1997
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K021416Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialDentsply Intl. · 2002 · cites it directly46descendants
- K970433Aquasil Rigid Smart Wetting Impression MaterialDentsply Intl. · 1997 · cites it directly28descendants
- K021413Aquasil Ultra Rigid Smart Wetting Impression MaterialDentsply Intl. · 2002 · 2 generations on27descendants
- K040053Precision VPS Impression MaterialDiscus Dental, Inc. · 2004 · 2 generations on25descendants
- K973782Aquasil XLV Smart Wetting Impression MaterialDentsply Intl. · 1997 · cites it directly25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| +1 | K021416 | Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| +1 | K970433 | Aquasil Rigid Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| +2 | K021413 | Aquasil Ultra Rigid Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| +2 | K040053 | Precision VPS Impression Material | Discus Dental, Inc. | 2004 | — |
| +1 | K973782 | Aquasil XLV Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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), 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? (60)
See all 604 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?
- Of its descendants, K021416 (Dentsply Intl., 2002) has gone furthest, with 46 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/K943574 · printed Nov 4, 2026
Cite this page
510(k) Report. “K943574: Capture Impression Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K943574
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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