510(k) Report

Devices descending from K203606

3 later devices reach Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252942ShaeferHShaeferh, LLC20260—
+1K232735EMA 3DEma Sleep Incorporated20241—
+2K252698NightGuard Aire MaxNightguard Express, LLC20250—