510(k) Report

Devices descending from K111361

4 later devices reach Planmed Nuance Excel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163328Planmed ClarityPlanmed OY20173—
+2K202822HelianthusMetaltronica Spa20210—
+2K192317Planmed Clarity 2D and Clarity SPlanmed OY20201—
+3K211720Planmed Clarity 2D, Planmed Clarify SPlanmed OY20220—