510(k) Report

Devices descending from K202344

4 later devices reach TiUltra Implants and Xeal Abutments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+1K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+2K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+2K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—