The following data is part of a premarket notification filed by 12th Man Technologies, Inc. with the FDA for Brx Pro Bruxism Guard.
| Device ID | K151933 |
| 510k Number | K151933 |
| Device Name: | BRX PRO Bruxism Guard |
| Classification | Mouthguard, Prescription |
| Applicant | 12TH MAN TECHNOLOGIES, INC. 7245 GARDEN GROVE BLVD., SUITE C Garden Grove, CA 92841 |
| Contact | Alex Stenzler |
| Correspondent | Alex Stenzler 12TH MAN TECHNOLOGIES, INC. 7245 GARDEN GROVE BLVD., SUITE C Garden Grove, CA 92841 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-14 |
| Decision Date | 2015-12-10 |
| Summary: | summary |