510(k) Report

Devices descending from K181869

6 later devices reach On1 Universal Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231940BruxZir® NOW SRCPrismatik Dentalcraft, Inc.20240—
+1K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+1K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+2K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+2K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+2K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—