Splintek, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250122SleepRight Snore AidMay 19, 2025
K212767SleepRight Select-Comfort Dental GuardDecember 22, 2021
K212706SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardDecember 13, 2021
K193577SleepRight ProRx Custom Dental GuardJune 1, 2020
K172223SleepRight ProRx Custom Dental GuardNovember 17, 2017