510(k) Report

Devices descending from K091660

6 later devices reach Custom Comfort Nightguard Version 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc.20250—
+1K180933DenTek Ultimate Dental GuardMedtech Products, Inc.20182—
+1K172452BruxorSleep Specialties, LLC20180—
+1K150492Ora-GUARD Dental Grind GuardBite Tech, Inc.20160—
+2K231865Mouth Guard (ATG0603R)Reazeal Corp20231—
+3K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore…1987 Media Limited20260—