510(k) · Cleared
ClearedAccusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prevest Denpro Limited · ELW Material, Impression
Cleared on Sep 9, 2022 as substantially equivalent to K171562 (Dreve Dentamid GmbH, 2018) after a 344-day review. Its family tree reaches back 6 generations to 1994. 3 later devices descend from it.
- Decided
- Sep 9, 2022
- Review
- 344 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K943574 (1994). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 5 generations backK021416 Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 4 generations backK040053 Precision VPS Impression MaterialDiscus Dental, Inc. · 2004
- 3 generations backK052090 Splash! Impression Material DeviceDiscus Dental, Inc. · 2005
- 2 generations backK053427 Fresh, Dental Impression MaterialExacta Dental Products, Inc. · 2006
- 1 generation backK171562 Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax monoDreve Dentamid GmbH · 2018
- This deviceK213244 Accusil Dental Impression Materials (Accusil Light Body Regular and…Prevest Denpro Limited · 2022
- Descendant · cites it directly · 1 of its ownK251724 Remi Impression MaterialGrindguard, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK261888 ClearClub Impression MaterialClearClub · 2026
- Descendant · cites it directly · 0 of its ownK251926 enCore Impression MaterialEncore Guards · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −5 | K021416 | Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −4 | K040053 | Precision VPS Impression Material | Discus Dental, Inc. | 2004 | — |
| −3 | K052090 | Splash! Impression Material Device | Discus Dental, Inc. | 2005 | — |
| −2 | K053427 | Fresh, Dental Impression Material | Exacta Dental Products, Inc. | 2006 | — |
| −1 | K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono | Dreve Dentamid GmbH | 2018 | — |
| 0 (this device) | K213244 | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set… | Prevest Denpro Limited | 2022 | — |
| +1 | K251724 | Remi Impression Material | Grindguard, Inc. | 2026 | — |
| +2 | K261888 | ClearClub Impression Material | ClearClub | 2026 | — |
| +1 | K251926 | enCore Impression Material | Encore Guards | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax monoSummary page 5…red for use of the ingredients are the same. Since no new risks are introduced, no biocompatibility testing was done. Predicate Device: Dynax Dental Impression Material K171562 Reference Devices: Fresh Impression Material K053427, President the Original, K220097, Aquasil Ultra + K152861 Substantial Equi… | 2018 |
| † | K053427 | Fresh, Dental Impression Material | 2006 |
| † | K220097 | PRESIDENT The Original | 2022 |
| † | K152861 | Aquasil Ultra + Smart Wetting Impression Material | 2016 |
What descends from it? (3)
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 28 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K251724 (Grindguard, Inc., 2026) has gone furthest, with 1 descendant 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. 2022, 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?
Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.
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/K213244 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213244: Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213244
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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