The following data is part of a premarket notification filed by Splintek, Inc. with the FDA for Sleepright Prorx Custom Dental Guard.
| Device ID | K193577 |
| 510k Number | K193577 |
| Device Name: | SleepRight ProRx Custom Dental Guard |
| Classification | Mouthguard, Over-the-counter |
| Applicant | Splintek, Inc. 15555 West 108th Street Lenexa, KS 66219 |
| Contact | Thomas W Brown |
| Correspondent | Thomas W Brown Splintek, Inc. 15555 West 108th Street Lenexa, KS 66219 |
| 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 | 2019-12-23 |
| Decision Date | 2020-06-01 |
| Summary: | summary |