510(k) Report

Devices descending from K161655

10 later devices reach On1 Concept through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220253Eco Abutment, Multiunit AbutmentDio Corporation20231—
+1K220339Esthetic Abutments Nobel Biocare N1Nobel Biocare Services AG20220—
+1K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+1K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+1K181869On1 Universal AbutmentNobel Biocare AB20186—
+2K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+2K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+2K231940BruxZir® NOW SRCPrismatik Dentalcraft, Inc.20240—
+2K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+3K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—