510(k) Report

Devices descending from K110468

10 later devices reach Freeway Comfort Bite Guard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc.20139—
+2K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—
+2K151933BRX PRO Bruxism Guard12th Man Technologies, Inc.20150—
+2K133037GrindguardGrind Guard Technologies, LLC20146—
+3K181099Bright GuardKoncept Innovators, LLC20195—
+4K240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd.20240—
+4K221369FBCC Night GuardFbcc, Inc.20223—
+5K252004enCore Night GuardEncore Guards20250—
+5K251778Remi Custom Night GuardRemi20251—
+6K253641Owl Night GuardOwl Dental Lab, Inc.20260—