510(k) · Cleared
ClearedenCore Impression Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Guards · SHI Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
Cleared on Mar 17, 2026 as substantially equivalent to K213244 (Prevest Denpro Limited, 2022) after a 267-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Mar 17, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- SHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K943574 (1994). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK943574 Capture Impression MaterialDentsply Intl. · 1994
- 6 generations backK021416 Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression MaterialDentsply Intl. · 2002
- 5 generations backK040053 Precision VPS Impression MaterialDiscus Dental, Inc. · 2004
- 4 generations backK052090 Splash! Impression Material DeviceDiscus Dental, Inc. · 2005
- 3 generations backK053427 Fresh, Dental Impression MaterialExacta Dental Products, Inc. · 2006
- 2 generations backK171562 Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax monoDreve Dentamid GmbH · 2018
- 1 generation backK213244 Accusil Dental Impression Materials (Accusil Light Body Regular and…Prevest Denpro Limited · 2022
- This deviceK251926 enCore Impression MaterialEncore Guards · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K943574 | Capture Impression Material | Dentsply Intl. | 1994 | — |
| −6 | K021416 | Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material | Dentsply Intl. | 2002 | — |
| −5 | K040053 | Precision VPS Impression Material | Discus Dental, Inc. | 2004 | — |
| −4 | K052090 | Splash! Impression Material Device | Discus Dental, Inc. | 2005 | — |
| −3 | K053427 | Fresh, Dental Impression Material | Exacta Dental Products, Inc. | 2006 | — |
| −2 | K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono | Dreve Dentamid GmbH | 2018 | — |
| −1 | K213244 | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set… | Prevest Denpro Limited | 2022 | — |
| 0 (this device) | K251926 | enCore Impression Material | Encore Guards | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 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 SHI? 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 SHI device
- #1 K251724 Remi Impression Materialscore 15.7 · 7 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K213244 | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil…Summary page 5…enCore Impression Material Impression Material Common Name: SHI Product Code: Class II Device Classification: K213244, Accusil Predicate Device: enCore Impression Material Impression Material Reference Device: K092319 S… | 2022 |
| † | K092319 | Star VPS, Model 80014-01, First Quater, Model 90649, First Half, Model 89387 | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K213244.
How does its category compare?
All SHI devicesSHI Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHI
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHI
185in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SHI
No recall names SHI since 2007.
Adverse event reports per year · SHI
No MAUDE report names SHI since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 4 | 185 | 0 | — |
What is it indicated for?
The EnCore Impression Material is intended for dental impression techniques to reproduce the structure of a patient's dentition to fabricate patient matched night guards and mouthguards.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251926 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251926: enCore 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/K251926
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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