Splintek, Inc. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
SleepRight Snore Aid510(k)May 19, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 19, 2025
SleepRight Select-Comfort Dental Guard510(k)Dec 22, 2021	—	510(k)Substantially Equivalent (Traditional)	Dec 22, 2021
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard510(k)Dec 13, 2021	—	510(k)Substantially Equivalent (Traditional)	Dec 13, 2021