510(k) · Cleared
ClearedAquasil Ultra Rigid 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 10, 2002 as substantially equivalent to K970433 (Dentsply Intl., 1997) after a 7-day review. Its family tree reaches back 2 generations to 1994. 27 later devices descend from it.
- Decided
- May 10, 2002
- Review
- 7 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K943574 (1994). 27 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 1 generation backK970433 Aquasil Rigid Smart Wetting Impression MaterialDentsply Intl. · 1997
- This deviceK021413 Aquasil Ultra Rigid Smart Wetting Impression MaterialDentsply Intl. · 2002
- Descendant · cites it directly · 17 of its ownK082560 Panasil Impression Materials, Including Putty, Binetics, Tray…Kettenbach GmbH & Co. KG · 2008
- 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 · cites it directly · 12 of its ownK133527 Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightOsstem Germany GmbH · 2014
- Descendant · 2 generations on · 11 of its ownK151262 Hyflex Heavy, Hyflex Mono, Hyflex LightOsstem Implant Co., Ltd. · 2015
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K082560Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and ContactKettenbach GmbH & Co. KG · 2008 · cites it directly17descendants
- K103164Vonflex Heavy, Vinflex LightVericom Co., Ltd. · 2010 · cites it directly13descendants
- K152766CharmFlexDentkist, Inc. · 2016 · 2 generations on12descendants
- K133527Suflex Putty, Suflex Heavy, Suflex Mono, Suflex LightOsstem Germany GmbH · 2014 · cites it directly12descendants
- K151262Hyflex Heavy, Hyflex Mono, Hyflex LightOsstem Implant Co., Ltd. · 2015 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −1 | K970433 | Aquasil Rigid Smart Wetting Impression Material | Dentsply Intl. | 1997 | — |
| 0 (this device) | K021413 | Aquasil Ultra Rigid Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| +1 | K082560 | Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and… | Kettenbach GmbH & Co. KG | 2008 | — |
| +1 | K103164 | Vonflex Heavy, Vinflex Light | Vericom Co., Ltd. | 2010 | — |
| +2 | K152766 | CharmFlex | Dentkist, Inc. | 2016 | — |
| +1 | K133527 | Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light | Osstem Germany GmbH | 2014 | — |
| +2 | K151262 | Hyflex Heavy, Hyflex Mono, Hyflex Light | Osstem Implant Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K970433 | Aquasil Rigid Smart Wetting Impression MaterialSummary page 1…L ULTRA RIGID SMART WETTING IMPRESSION MATERIAL CLASSIFICATION NAME: Impression Material (872.3660) PREDICATE DEVICES: Aquasil Rigid™ Smart Wetting Impression Material K970433 DEVICE DESCRIPTION: AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL is a two-part catalyst/base hydrophilic vinylpolysilox… | 1997 |
What descends from it? (27)
See all 274 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 8 years and passes through 1 company; a new generation was cleared every 5.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K082560 (Kettenbach GmbH & Co. KG, 2008) has gone furthest, with 17 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?
Used as an impression material in a dual phase impression technique. It 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 heavy 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/K021413 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021413: Aquasil Ultra Rigid Smart Wetting Impression Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021413
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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