510(k) Report

Devices descending from K121272

5 later devices reach Protech Dent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193577SleepRight ProRx Custom Dental GuardSplintek, Inc.20202—
+1K191033LunaGuard Nighttime Dental ProtectorMckeon Products20190—
+1K172223SleepRight ProRx Custom Dental GuardSplintek, Inc.20173—
+2K250743Remvia NightGuardRemvia20250—
+2K212706SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardSplintek, Inc.20210—