The following data is part of a premarket notification filed by Doc Brands, Inc. with the FDA for Protect-it Custom Fit Dental Guard.
| Device ID | K222424 |
| 510k Number | K222424 |
| Device Name: | Protect-It Custom Fit Dental Guard |
| Classification | Mouthguard, Over-the-counter |
| Applicant | DOC Brands, Inc. 407 E. Lancaster Avenue Wayne, PA 19087 |
| Contact | Sean Stubbs |
| Correspondent | Eric Mowell DOC Brands, Inc. 407 E. Lancaster Avenue Wayne, PA 19087 |
| 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 | 2022-08-11 |
| Decision Date | 2022-10-07 |