510(k) Report

Devices descending from K962155

8 later devices reach Gill-Thomas-Cosman (GTC) Dental Tray through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153270TruGuard Custom Tongue and Jaw PositionerBionix Development Corp.20164—
+1K991237Xplan-2 with Head and Neck Localizer, Model HNLRadionics, Inc.199921
+2K200652Lollipop BiteBlockRadtec Medical Devices, Inc.20200—
+2K183374GrayDuck StentPoll Medical, LLC20192—
+2K081935Stereotactic Head and Neck Localizer, Model 50-100Aktina Medical Physics Corp.20081—
+3K232293kallisio stentra™ oral stentKallisio, Inc.20230—
+3K231852BinkieRTPapricalab20230—
+3K103616Pinpoint Stereotactic Head and Neck LocalizerAktina Medical Physics Corp.20110—