K240810 is an FDA 510(k) clearance for the Anti Grinding Guard. This device is classified as a Mouthguard, Over-the-counter.
Submitted by Xiamen Yizhou Imp. & Exp. Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on May 24, 2024, 60 days after receiving the submission on March 25, 2024.
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 | K240810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2024 |
| Decision Date | May 24, 2024 |
| Days to Decision | 60 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. |