510(k) Report

Devices descending from K014079

33 later devices reach DR. Hays Bite Guard through their predicates, nearest generation first.

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