510(k) Report

Devices descending from K111066

7 later devices reach Migra Tab, Quicksplint Migraine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222845Clench Relief Mouth Piece PRO RX, Clench Relief Mouth PieceFrey Oral Technologies, LLC20230—
+1K170985Urbanek DeviceTmj Services, LLC20174—
+1K151933BRX PRO Bruxism Guard12th Man Technologies, Inc.20150—
+2K182820The PODAdvanced Facialdontics, LLC20193—
+3K203596Panthera Occlusal AppliancePanthera Dental, Inc.20212—
+4K230495Serena Sleep Night GuardMeris Investment Group20231—
+5K230548Myoaligner ApplianceMyohealth Technologies, LLC20240—