510(k) Report

Devices descending from K171674

6 later devices reach Angel Align System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203688Clear AlignerWuxi EA Medical Instruments Technologies Limited.20213—
+1K191990OSW Aligner SystemOsw Manufacturing, LLC20191—
+2K240501Spark™ Clear Aligner SystemOrmco Corporation20241—
+2K223517Clear AlignerWuxi EA Medical Instruments Technologies Limited.20231—
+2K2002143D Predict3D Smile USA, Inc.20200—
+3K250487SparkTM Clear Aligner SystemOrmco Corporation20250—