K180933 is an FDA 510(k) clearance for the DenTek Ultimate Dental Guard. This device is classified as a Mouthguard, Over-the-counter.
Submitted by Medtech Products, Inc. (Tarrytown, US). The FDA issued a Cleared decision on September 17, 2018, 160 days after receiving the submission on April 10, 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 | K180933 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2018 |
| Decision Date | September 17, 2018 |
| Days to Decision | 160 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. |