K253641 is an FDA 510(k) clearance for the Owl Night Guard. This device is classified as a Mouthguard, Over-the-counter.
Submitted by Owl Dental Lab, Inc. (San Leandro, US). The FDA issued a Cleared decision on February 26, 2026, 99 days after receiving the submission on November 19, 2025.
This device falls under the Dental FDA review panel. To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding..
| 510(k) Number | K253641 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2025 |
| Decision Date | February 26, 2026 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | OBR — Mouthguard, Over-the-counter |
| Device Class | — |
| Definition | To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding. |