510(k) Report

Devices descending from K121365

4 later devices reach Thermoformed Mouthguards through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210011JS Dental Lab Mouth GuardAmpower Dental Laboratories, LLC20212—
+1K202465Night Guard3D Diagnostix, Inc.20200—
+2K241369LIJIA Night GuardLijia, LLC20241—
+3K243516Remi Custom Night GuardGrindguard, Inc.20250—