510(k) Report

Devices descending from K900389

12 later devices reach Temporary Crown Matrix Buttons through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082723GrindguardGrind Guard Technologies, LLC200910—
+1K033227Luxaform PlusDmg USA, Inc.20040—
+2K133037GrindguardGrind Guard Technologies, LLC20146—
+2K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc.20139—
+3K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—
+3K181099Bright GuardKoncept Innovators, LLC20195—
+3K151933BRX PRO Bruxism Guard12th Man Technologies, Inc.20150—
+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—