Splintek, Inc.
Medical device manufacturer in Lenexa, KS.
5510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250122 | SleepRight Snore AidLRK · Traditional | 05/19/2025SE |
| K212767 | SleepRight Select-Comfort Dental GuardMQC · Traditional | 12/22/2021SE |
| K212706 | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardOBR · Traditional | 12/13/2021SE |
| K193577 | SleepRight ProRx Custom Dental GuardOBR · Traditional | 06/01/2020SE |
| K172223 | SleepRight ProRx Custom Dental GuardOBR · Traditional | 11/17/2017SE |