510(k) Report

Devices descending from K063483

31 later devices reach Den Tek Nightguard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120103Rest Assured Generation Iii Dental ProtectorRanir, LLC20120—
+1K091660Custom Comfort Nightguard Version 2Den Tek Oral Care, Inc.20096—
+1K083400Custom Comfort NightguardDen Tek Oral Care, Inc.200810—
+1K072147Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc.200719—
+2K250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc.20250—
+2K180933DenTek Ultimate Dental GuardMedtech Products, Inc.20182—
+2K172452BruxorSleep Specialties, LLC20180—
+2K150492Ora-GUARD Dental Grind GuardBite Tech, Inc.20160—
+2K132469The Bite GuardInternational Profit Builders, Inc.20140—
+2K121272Protech DentAkervall Technologies, Inc.20125—
+2K113326Oral B Plus Outlast Night Time Dental GuardOralabs, Inc.20122—
+2K091175Grind NO More Version 2 and 3Ranir, LLC20094—
+2K082301Grind NO MorePlacontrol, Inc.20088—
+2K081669Improved Comfort-Fit NightguardDen Tek Oral Care, Inc.20081—
+2K072968Stressgard NightguardTotalgard Corporation20080—
+3K231865Mouth Guard (ATG0603R)Reazeal Corp20231—
+3K193577SleepRight ProRx Custom Dental GuardSplintek, Inc.20202—
+3K183315CustMBite Dental GuardDental Choice Holdings, LLC20190—
+3K191033LunaGuard Nighttime Dental ProtectorMckeon Products20190—
+3K172223SleepRight ProRx Custom Dental GuardSplintek, Inc.20173—
+3K151149Ready-FitDen Tek Oral Care, Inc.20152—
+3K123849New Comfort-Fit Dental GuardDen Tek Oral Care, Inc.20130—
+3K112879Rest Assured Ready to Wear Nite ProtectorRanir, LLC20122—
+3K094020Grind NO More Generation IIRanir, LLC20100—
+4K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore…1987 Media Limited20260—
+4K250743Remvia NightGuardRemvia20250—
+4K222424Protect-It Custom Fit Dental GuardDoc Brands, Inc.20220—
+4K212706SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardSplintek, Inc.20210—
+4K202974DenTek Fresh Protect Dental GuardMedtech Products, Inc.20200—
+4K133423Rest Assured Extra Comfort Nite ProtectorRanir, LLC20131—
+5K232238Goyo Mouthpiece SDimedikorea20240—