510(k) Report

Devices descending from K221369

3 later devices reach FBCC Night Guard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252004enCore Night GuardEncore Guards20250—
+1K251778Remi Custom Night GuardRemi20251—
+2K253641Owl Night GuardOwl Dental Lab, Inc.20260—