510(k) Report

Devices descending from K122424

13 later devices reach Isus Implant Suprastructures through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+1K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+1K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+1K151439Atlantis IsusDentsply International, Inc.20160—
+2K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+2K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+3K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+3K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+3K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K241032BellaTek BarsBiomet 3i, LLC20241—
+4K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+4K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+5K260940BellaTek BarsZimVie US Corp, LLC20260—