510(k) Report

Devices descending from K203737

10 later devices reach Spark Clear Aligner System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240501Spark™ Clear Aligner SystemOrmco Corporation20241—
+1K212660Smylio Invisible Clear AlignersSmylio, Inc.20217—
+2K250487SparkTM Clear Aligner SystemOrmco Corporation20250—
+2K233356Illusion Aligner Pro: Illusion Aligner FLXLaxmi Dental Export Pvt., Ltd.20241—
+2K220726K ClearKline Europe GmbH20221—
+2K211510uLab Systems Dental Aligner KitUlab Systems, Inc.20222—
+3K260527FACE4D AlignerAvinent Implant System S.L.U.20260—
+3K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited20260—
+3K223141STR8 Clear AlignerStr8 Oral Care20231—
+4K240038Clear Moves AlignersSpace Maintainers Laboratories (Sml)20240—