510(k) Report

Devices descending from K181099

5 later devices reach Bright Guard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd.20240—
+1K221369FBCC Night GuardFbcc, Inc.20223—
+2K252004enCore Night GuardEncore Guards20250—
+2K251778Remi Custom Night GuardRemi20251—
+3K253641Owl Night GuardOwl Dental Lab, Inc.20260—