510(k) Report

Devices descending from K080156

67 later devices reach Osseospeed TM Profile System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+1K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+1K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+1K103759Atlantis Abutment in Zirconia for Osseospeed TX Profile ImplantAstra Tech, Inc.201119—
+1K103280Bhdental Implant SystemBhdental, Ltd.20110—
+1K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+2K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+2K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+2K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+2K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+2K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+2K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+3K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+3K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+3K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+3K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+3K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+3K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+3K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+3K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+3K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+3K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+3K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+3K152555Dental Implant SystemAriabio International, Inc.20160—
+3K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+3K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+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—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+4K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+5K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+5K232383iPhysio® SystemEuroteknika20250—
+5K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+5K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+6K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—