510(k) Report

Devices descending from K981546

39 later devices reach Nti Clenching Suppression System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091880Clayton Intra-Aural Device (Cid)Ascentia Health Incorporated20100—
+1K040315Myohealth Clenching InhibitorMci-Myohealth Systems200411—
+1K014079DR. Hays Bite GuardInventive Resources, Inc.200233—
+2K121365Thermoformed MouthguardsGlidewell Laboratories-Sleep Devices Group20124—
+2K112868Dreamgard Rem-Soft, Dreamgard Rem-Lite, Dreamgard Rem-Ultra, Dreamgard Rem-MaxDreamgard, Inc.20120—
+2K102909Somnobrux SplintsSomnomed, Inc.20114—
+2K111066Migra Tab, Quicksplint MigraineMigratherapy, LLC20117—
+2K061122Night GuardAlpine Oral Care, LLC20070—
+2K063229Rest Assured Nite ProtectorRanir, LLC20067—
+2K024261Dental ProtectorDental Concepts, LLC200320—
+3K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—
+3K222845Clench Relief Mouth Piece PRO RX, Clench Relief Mouth PieceFrey Oral Technologies, LLC20230—
+3K210011JS Dental Lab Mouth GuardAmpower Dental Laboratories, LLC20212—
+3K203596Panthera Occlusal AppliancePanthera Dental, Inc.20212—
+3K202465Night Guard3D Diagnostix, Inc.20200—
+3K170985Urbanek DeviceTmj Services, LLC20174—
+3K151933BRX PRO Bruxism Guard12th Man Technologies, Inc.20150—
+3K143623Narval BruxResmed Sas20150—
+3K094020Grind NO More Generation IIRanir, LLC20100—
+3K091792Rest Assured Generation II Dental ProtectorRanir Corporation20095—
+3K073220The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc.200717—
+4K241369LIJIA Night GuardLijia, LLC20241—
+4K230495Serena Sleep Night GuardMeris Investment Group20231—
+4K182820The PODAdvanced Facialdontics, LLC20193—
+4K132469The Bite GuardInternational Profit Builders, Inc.20140—
+4K133423Rest Assured Extra Comfort Nite ProtectorRanir, LLC20131—
+4K120103Rest Assured Generation Iii Dental ProtectorRanir, LLC20120—
+4K112879Rest Assured Ready to Wear Nite ProtectorRanir, LLC20122—
+4K082723GrindguardGrind Guard Technologies, LLC200910—
+5K243516Remi Custom Night GuardGrindguard, Inc.20250—
+5K232238Goyo Mouthpiece SDimedikorea20240—
+5K133037GrindguardGrind Guard Technologies, LLC20146—
+5K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc.20139—
+6K181099Bright GuardKoncept Innovators, LLC20195—
+7K240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd.20240—
+7K221369FBCC Night GuardFbcc, Inc.20223—
+8K252004enCore Night GuardEncore Guards20250—
+8K251778Remi Custom Night GuardRemi20251—
+9K253641Owl Night GuardOwl Dental Lab, Inc.20260—