510(k) Report

Devices descending from K211510

2 later devices reach uLab Systems Dental Aligner Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223141STR8 Clear AlignerStr8 Oral Care20231—
+2K240038Clear Moves AlignersSpace Maintainers Laboratories (Sml)20240—