510(k) Report

Devices descending from K083400

10 later devices reach Custom Comfort Nightguard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113326Oral B Plus Outlast Night Time Dental GuardOralabs, Inc.20122—
+1K091660Custom Comfort Nightguard Version 2Den Tek Oral Care, Inc.20096—
+2K250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc.20250—
+2K183315CustMBite Dental GuardDental Choice Holdings, LLC20190—
+2K180933DenTek Ultimate Dental GuardMedtech Products, Inc.20182—
+2K172452BruxorSleep Specialties, LLC20180—
+2K150492Ora-GUARD Dental Grind GuardBite Tech, Inc.20160—
+2K132469The Bite GuardInternational Profit Builders, Inc.20140—
+3K231865Mouth Guard (ATG0603R)Reazeal Corp20231—
+4K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore…1987 Media Limited20260—