K243516 is an FDA 510(k) clearance for the Remi Custom Night Guard. This device is classified as a Mouthguard, Prescription.
Submitted by Grindguard, Inc. (San Francisco, US). The FDA issued a Cleared decision on February 10, 2025, 89 days after receiving the submission on November 13, 2024.
This device falls under the Dental FDA review panel.
| 510(k) Number | K243516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2024 |
| Decision Date | February 10, 2025 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |