Splintek, Inc. - FDA 510(k) Cleared Devices
5
Total
5
Cleared
0
Denied
Splintek, Inc. has 5 FDA 510(k) cleared medical devices. Based in Lenexa, US.
Latest FDA clearance: May 2025. Active since 2017. Primary specialty: Dental.
Browse the FDA 510(k) cleared devices submitted by Splintek, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Splintek, Inc.
5 devices
Cleared
May 19, 2025
SleepRight Snore Aid
Dental
122d
Cleared
Dec 22, 2021
SleepRight Select-Comfort Dental Guard
Dental
113d
Cleared
Dec 13, 2021
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
Dental
109d
Cleared
Jun 01, 2020
SleepRight ProRx Custom Dental Guard
Dental
161d
Cleared
Nov 17, 2017
SleepRight ProRx Custom Dental Guard
Dental
116d