Medical Device Manufacturer · US , Lenexa , KS

Splintek, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2017

Recent clearances: SleepRight Snore Aid, SleepRight Select-Comfort Dental Guard, SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Splintek, Inc. Dental ✕

5 devices

1-5 of 5

Cleared May 19, 2025

SleepRight Snore Aid

Cleared Dec 22, 2021

SleepRight Select-Comfort Dental Guard

Cleared Dec 13, 2021

SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard

Cleared Jun 01, 2020

SleepRight ProRx Custom Dental Guard

Cleared Nov 17, 2017

SleepRight ProRx Custom Dental Guard