510(k) · Cleared
ClearedFresh, Dental Impression Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exacta Dental Products, Inc. · ELW Material, Impression
Cleared on Jan 13, 2006 as substantially equivalent to K052090 (Discus Dental, Inc., 2005) after a 36-day review. Its family tree reaches back 4 generations to 1994. 5 later devices descend from it.
- Decided
- Jan 13, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943574 (1994). 5 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 3 generations backK021416 Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 2 generations backK040053 Precision VPS Impression MaterialDiscus Dental, Inc. · 2004
- 1 generation backK052090 Splash! Impression Material DeviceDiscus Dental, Inc. · 2005
- This deviceK053427 Fresh, Dental Impression MaterialExacta Dental Products, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK171562 Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax monoDreve Dentamid GmbH · 2018
- Descendant · 2 generations on · 3 of its ownK213244 Accusil Dental Impression Materials (Accusil Light Body Regular and…Prevest Denpro Limited · 2022
- Descendant · 3 generations on · 1 of its ownK251724 Remi Impression MaterialGrindguard, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK261888 ClearClub Impression MaterialClearClub · 2026
- Descendant · 3 generations on · 0 of its ownK251926 enCore Impression MaterialEncore Guards · 2026
Most influential descendants
Showing 5 of 5 · See all- K171562Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax monoDreve Dentamid GmbH · 2018 · cites it directly4descendants
- K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil…Prevest Denpro Limited · 2022 · 2 generations on3descendants
- K251724Remi Impression MaterialGrindguard, Inc. · 2026 · 3 generations on1descendant
- K261888ClearClub Impression MaterialClearClub · 2026 · 4 generations on0descendants
- K251926enCore Impression MaterialEncore Guards · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −3 | K021416 | Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −2 | K040053 | Precision VPS Impression Material | Discus Dental, Inc. | 2004 | — |
| −1 | K052090 | Splash! Impression Material Device | Discus Dental, Inc. | 2005 | — |
| 0 (this device) | 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 | — |
| +2 | K213244 | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set… | Prevest Denpro Limited | 2022 | — |
| +3 | K251724 | Remi Impression Material | Grindguard, Inc. | 2026 | — |
| +4 | K261888 | ClearClub Impression Material | ClearClub | 2026 | — |
| +3 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K052090 | Splash! Impression Material DeviceSummary page 1…ls. Exacta Dental Products, Inc has determined that the Fresh, Dental Imipression Material are substantially equivalent to the performance of these predicate materials: K 052090, Splash Dental Impression Material.… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono | 2018 | 4 |
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 12 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K171562 (Dreve Dentamid GmbH, 2018) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K052090.
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?
Fresh, Dental Impression Material is intended for use with all crowns, bridges, occiusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053427: Fresh, Dental 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/K053427
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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