K251724 is an FDA 510(k) clearance for the Remi 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 Grindguard, Inc. (San Francisco, US). The FDA issued a Cleared decision on February 25, 2026, 266 days after receiving the submission on June 4, 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 | K251724 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2025 |
| Decision Date | February 25, 2026 |
| Days to Decision | 266 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. |