510(k) Report

Devices descending from K012911

675 later devices reach 3I Locater Abutment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB201118—
+5K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+5K101545Genesis Implant SystemKeystone Dental2010153
+5K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd.20100—
+5K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+5K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+5K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+5K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+5K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+5K082299Vericore Implant AbutmentsWhip-Mix Corp.20082—
+5K072595Omni-TightBasic Dental Implant Systems, Inc.20081—
+5K073486Dentis Dental Implant SystemDentis Co., Ltd.200825—
+5K073540Atlantis Abutment in Zirconia for Biohorizons ImplantAtlantis Components, Inc.20081—
+5K072483Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in…Atlantis Components, Inc.200728—
+5K061629Certain Prevail Dental ImplantImplant Innovations, Inc.20074—
+6K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+6K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+6K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+6K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+6K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+6K232383iPhysio® SystemEuroteknika20250—
+6K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+6K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+6K242261Accelx Implant SystemBiotech Dental, LLC20240—
+6K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+6K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+6K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+6K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+6K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+6K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K220823Preat AbutmentsPreat Corporation202216
+6K211872PiezoImplant SystemRex Implants, Inc.20220—
+6K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+6K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K213599SuperLineDentium Co., Ltd.20220—
+6K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+6K212538DESS Dental ImplantsTerrats Medical SL20211—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+6K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K193352AbutmentCADExocad GmbH20210—
+6K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+6K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+6K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+6K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+6K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB20202—
+6K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+6K200100Abutment Design3Shape A/S20203—
+6K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+6K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+6K191152MIS Ti-base AbutmentDentsply Sirona20201—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+6K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+6K193335SherlockOpen Implants, LLC20203—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K190552JJ Implant SystemJj Implants20190—
+6K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+6K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+6K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+6K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+6K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—