The following data is part of a premarket notification filed by Brux Night Guard with the FDA for Brux Night Guard.
| Device ID | K181361 |
| 510k Number | K181361 |
| Device Name: | Brux Night Guard |
| Classification | Mouthguard, Prescription |
| Applicant | Brux Night Guard 8201 Canoga Ave. #9066 Canoga Park, CA 91309 |
| Contact | John Scalco |
| Correspondent | John Scalco Brux Night Guard 8201 Canoga Ave. #9066 Canoga Park, CA 91309 |
| Product Code | MQC |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-23 |
| Decision Date | 2019-04-11 |