510(k) Report

Devices descending from K220816

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252446BruxZir® NOWPrismatik Dentalcraft, Inc.20250—
+1K250223BruxZir® Esthetic NOWPrismatik Dentalcraft, Inc.20250—