510(k) · Cleared
ClearedDaybreak Impression Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sleepcare, LLC · SHI Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
Cleared on Oct 20, 2026 after a 96-day review. FDA has not posted a summary or statement for it, so its predicates are not known.
- Decided
- Oct 20, 2026
- Review
- 96 days
- Class
- Class II
- Product code
- SHI
- Recalls
- None
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 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
- #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?
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.
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 | — |
https://510kreport.com/device/K262421 · printed Nov 5, 2026
Cite this page
510(k) Report. “K262421: Daybreak 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/K262421
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Record history
- FDA decision record loaded Nov 3, 2026
- Page last updated Nov 3, 2026