Submission Details
| 510(k) Number | K251724 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Remi Impression Material
Feb 2026
Decision
266d
Days
Class 2
Risk
About This 510(k) Submission
K251724 is an FDA 510(k) clearance for the Remi Impression Material, 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 review panel. Regulated under 21 CFR 872.3660.
Device Classification
| 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. |