510(k) Report

Devices descending from K072147

19 later devices reach Den Tek Comfort Fit Nightguard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132469The Bite GuardInternational Profit Builders, Inc.20140—
+1K121272Protech DentAkervall Technologies, Inc.20125—
+1K091175Grind NO More Version 2 and 3Ranir, LLC20094—
+1K082301Grind NO MorePlacontrol, Inc.20088—
+1K081669Improved Comfort-Fit NightguardDen Tek Oral Care, Inc.20081—
+1K072968Stressgard NightguardTotalgard Corporation20080—
+2K193577SleepRight ProRx Custom Dental GuardSplintek, Inc.20202—
+2K191033LunaGuard Nighttime Dental ProtectorMckeon Products20190—
+2K172223SleepRight ProRx Custom Dental GuardSplintek, Inc.20173—
+2K151149Ready-FitDen Tek Oral Care, Inc.20152—
+2K123849New Comfort-Fit Dental GuardDen Tek Oral Care, Inc.20130—
+2K112879Rest Assured Ready to Wear Nite ProtectorRanir, LLC20122—
+2K094020Grind NO More Generation IIRanir, LLC20100—
+3K250743Remvia NightGuardRemvia20250—
+3K222424Protect-It Custom Fit Dental GuardDoc Brands, Inc.20220—
+3K212706SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardSplintek, Inc.20210—
+3K202974DenTek Fresh Protect Dental GuardMedtech Products, Inc.20200—
+3K133423Rest Assured Extra Comfort Nite ProtectorRanir, LLC20131—
+4K232238Goyo Mouthpiece SDimedikorea20240—