510(k) Report

Devices descending from K222418

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.20260—
+1K242929Fas Aligner SystemXplora 3D Europe S.L20240—