510(k) Report

Devices descending from K123161

9 later devices reach Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original… through their predicates, nearest generation first.

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