FDA 510(k) Applications Submitted by Splintek, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K172223 07/24/2017 SleepRight ProRx Custom Dental Guard Splintek, Inc.
K193577 12/23/2019 SleepRight ProRx Custom Dental Guard Splintek, Inc.
K212706 08/26/2021 SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard Splintek, Inc.
K212767 08/31/2021 SleepRight Select-Comfort Dental Guard Splintek, Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact