K232238 is an FDA 510(k) clearance for the Goyo Mouthpiece S. This device is classified as a Mouthguard, Over-the-counter.
Submitted by Dimedikorea (Busan, KR). The FDA issued a Cleared decision on April 17, 2024, 264 days after receiving the submission on July 28, 2023.
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 | K232238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2023 |
| Decision Date | April 17, 2024 |
| Days to Decision | 264 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. |