510(k) Report

Devices descending from K143120

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

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