K181099 is an FDA 510(k) clearance for the Bright Guard. This device is classified as a Mouthguard, Over-the-counter.
Submitted by Koncept Innovators, LLC (Myrtle Beach, US). The FDA issued a Cleared decision on January 18, 2019, 267 days after receiving the submission on April 26, 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 | K181099 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2018 |
| Decision Date | January 18, 2019 |
| Days to Decision | 267 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. |