510(k) Report

Devices descending from K013438

14 later devices reach Frialit-2 Estheticbase Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122424Isus Implant SuprastructuresDentsply International, Inc.201313—
+2K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+2K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+2K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+2K151439Atlantis IsusDentsply International, Inc.20160—
+3K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+3K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K241032BellaTek BarsBiomet 3i, LLC20241—
+5K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+5K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K260940BellaTek BarsZimVie US Corp, LLC20260—