K241369 is an FDA 510(k) clearance for the LIJIA Night Guard. This device is classified as a Mouthguard, Prescription.
Submitted by Lijia, LLC (Santa Ana, US). The FDA issued a Cleared decision on August 22, 2024, 100 days after receiving the submission on May 14, 2024.
This device falls under the Dental FDA review panel.
| 510(k) Number | K241369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2024 |
| Decision Date | August 22, 2024 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |