510(k) Report

Devices descending from K040315

11 later devices reach Myohealth Clenching Inhibitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112868Dreamgard Rem-Soft, Dreamgard Rem-Lite, Dreamgard Rem-Ultra, Dreamgard Rem-MaxDreamgard, Inc.20120—
+1K102909Somnobrux SplintsSomnomed, Inc.20114—
+1K111066Migra Tab, Quicksplint MigraineMigratherapy, LLC20117—
+2K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—
+2K222845Clench Relief Mouth Piece PRO RX, Clench Relief Mouth PieceFrey Oral Technologies, LLC20230—
+2K203596Panthera Occlusal AppliancePanthera Dental, Inc.20212—
+2K170985Urbanek DeviceTmj Services, LLC20174—
+2K151933BRX PRO Bruxism Guard12th Man Technologies, Inc.20150—
+2K143623Narval BruxResmed Sas20150—
+3K230495Serena Sleep Night GuardMeris Investment Group20231—
+3K182820The PODAdvanced Facialdontics, LLC20193—