K113326 is an FDA 510(k) clearance for the ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD. This device is classified as a Mouthguard, Over-the-counter.
Submitted by Oralabs, Inc. (Parker, US). The FDA issued a Cleared decision on June 27, 2012, 230 days after receiving the submission on November 10, 2011.
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 | K113326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 2011 |
| Decision Date | June 27, 2012 |
| Days to Decision | 230 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. |