510(k) Report

Devices descending from K212660

7 later devices reach Smylio Invisible Clear Aligners through their predicates, nearest generation first.

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