510(k) Report

Devices descending from K200908

2 later devices reach iSMILE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221537Nightwear AlignersSmylio, Inc.20230—
+1K222308Al Smile AlignerNanjing Jiahe Dental Technology Co., Ltd.20220—