510(k) Report

Devices descending from K130643

5 later devices reach Acceledent Aura through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153048AcceleDent AuraOrthoaccel Technologies, Inc.20162—
+1K143120OrthoPulseBiolux Research, Ltd.20154—
+2K230905OrthoPulse 2.0E (OPi2E-100)Biolux Technology GmbH20230—
+2K183018VPro5Propel Orthodontics, LLC20190—
+2K170093AcceleDent OptimaOrthoaccel Technology, Inc.20170—