510(k) Report

Devices descending from K212448

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221022NextDent Ortho FlexVertex-Dental B.V.20221—
+2K251415Additively Manufactured Aligner ResinAidite (Qinhuangdao) Technology Co., Ltd.20250—