510(k) Report

Devices descending from K193577

2 later devices reach SleepRight ProRx Custom Dental Guard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250743Remvia NightGuardRemvia20250—
+1K212706SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardSplintek, Inc.20210—