K181005 is an FDA 510(k) clearance for the ClenchGuard. This device is classified as a Mouthguard, Over-the-counter.
Submitted by Boyd Research, Inc. (Solana Beach, US). The FDA issued a Cleared decision on January 15, 2020, 639 days after receiving the submission on April 16, 2018.
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 | K181005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2018 |
| Decision Date | January 15, 2020 |
| Days to Decision | 639 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| 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. |