The following data is part of a premarket notification filed by Boyd Research, Inc. with the FDA for Clenchguard.
| Device ID | K181005 |
| 510k Number | K181005 |
| Device Name: | ClenchGuard |
| Classification | Mouthguard, Over-the-counter |
| Applicant | Boyd Research, Inc. 506 Pacific Ave Solana Beach, CA 92075 |
| Contact | James Boyd |
| Correspondent | James Boyd Boyd Research, Inc. 5820 Bali Way S St. Pete Beach, FL 33706 |
| Product Code | OBR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-16 |
| Decision Date | 2020-01-15 |