510(k) Report

Devices descending from K130999

18 later devices reach Osseospeed Profile EV through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+1K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+1K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+1K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+2K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+2K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+2K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+2K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+3K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+3K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+3K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+3K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+4K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+4K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+4K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+4K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+5K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—