510(k) Report

Devices descending from K153270

4 later devices reach TruGuard Custom Tongue and Jaw Positioner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200652Lollipop BiteBlockRadtec Medical Devices, Inc.20200—
+1K183374GrayDuck StentPoll Medical, LLC20192—
+2K232293kallisio stentra™ oral stentKallisio, Inc.20230—
+2K231852BinkieRTPapricalab20230—