510(k) Report

Devices descending from K203688

3 later devices reach Clear Aligner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240501Spark™ Clear Aligner SystemOrmco Corporation20241—
+1K223517Clear AlignerWuxi EA Medical Instruments Technologies Limited.20231—
+2K250487SparkTM Clear Aligner SystemOrmco Corporation20250—