510(k) Report

Devices descending from K022809

46 later devices reach EZ Splint & EZ Splint PM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc.20139—
+1K121365Thermoformed MouthguardsGlidewell Laboratories-Sleep Devices Group20124—
+1K072147Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc.200719—
+1K061122Night GuardAlpine Oral Care, LLC20070—
+1K063229Rest Assured Nite ProtectorRanir, LLC20067—
+1K062828Mouthguard and Aligner MaterialsDentsply Intl., Inc.20066—
+2K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—
+2K210011JS Dental Lab Mouth GuardAmpower Dental Laboratories, LLC20212—
+2K202465Night Guard3D Diagnostix, Inc.20200—
+2K200125Thermoforming Sheet MaterialsErkodent Erich Kopp GmbH20201—
+2K151933BRX PRO Bruxism Guard12th Man Technologies, Inc.20150—
+2K134015M-PM-DiscMerz Dental GmbH20141—
+2K132469The Bite GuardInternational Profit Builders, Inc.20140—
+2K133037GrindguardGrind Guard Technologies, LLC20146—
+2K121272Protech DentAkervall Technologies, Inc.20125—
+2K094020Grind NO More Generation IIRanir, LLC20100—
+2K091792Rest Assured Generation II Dental ProtectorRanir Corporation20095—
+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—
+2K072522Thermoform Sheet Materials and AccessoriesDentsply International, Inc.20073—
+3K241369LIJIA Night GuardLijia, LLC20241—
+3K241311Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B)…Bernhard Förster GmbH20240—
+3K193577SleepRight ProRx Custom Dental GuardSplintek, Inc.20202—
+3K191836Ceramill A-SplintAmann Girrbach AG20190—
+3K191033LunaGuard Nighttime Dental ProtectorMckeon Products20190—
+3K181099Bright GuardKoncept Innovators, LLC20195—
+3K172223SleepRight ProRx Custom Dental GuardSplintek, Inc.20173—
+3K151149Ready-FitDen Tek Oral Care, Inc.20152—
+3K133423Rest Assured Extra Comfort Nite ProtectorRanir, LLC20131—
+3K123849New Comfort-Fit Dental GuardDen Tek Oral Care, Inc.20130—
+3K120103Rest Assured Generation Iii Dental ProtectorRanir, LLC20120—
+3K112879Rest Assured Ready to Wear Nite ProtectorRanir, LLC20122—
+3K080246Composite Aligner ButtonDentsply Interntional20080—
+4K250743Remvia NightGuardRemvia20250—
+4K243516Remi Custom Night GuardGrindguard, Inc.20250—
+4K240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd.20240—
+4K232238Goyo Mouthpiece SDimedikorea20240—
+4K221369FBCC Night GuardFbcc, Inc.20223—
+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—
+5K252004enCore Night GuardEncore Guards20250—
+5K251778Remi Custom Night GuardRemi20251—
+6K253641Owl Night GuardOwl Dental Lab, Inc.20260—