K251926 is an FDA 510(k) clearance for the enCore Impression Material. This device is classified as a Impression Material For Fabrication Of Patient-matched Mouthguards, Over-the-counter (Class II - Special Controls, product code SHI).
Submitted by Encore Guards (Santa Ana, US). The FDA issued a Cleared decision on March 17, 2026, 267 days after receiving the submission on June 23, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660. An Over-the-counter Device That Is Intended To Reproduce The Structure Of A Patient's Teeth And Gums For The Fabrication Of Patient-matched Mouthguards/nightguards..
| 510(k) Number | K251926 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2025 |
| Decision Date | March 17, 2026 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | SHI — Impression Material For Fabrication Of Patient-matched Mouthguards, Over-the-counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |
| Definition | An Over-the-counter Device That Is Intended To Reproduce The Structure Of A Patient's Teeth And Gums For The Fabrication Of Patient-matched Mouthguards/nightguards. |