510(k) Report

Devices descending from K944069

506 later devices reach Restore TPS Lhex Cylinder Endosseous Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K160786RODO Abutment SystemRodo Medical, Inc.20162—
+6K1514553Shape Abutment Designer Software3Shape A/S201610—
+6K160483Burn-out Cylinder and Angled Screw AbutmentsDentium Co., Ltd.20160—
+6K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+6K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+6K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+6K160244VARIOuniteThommen Medical AG201615—
+6K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+6K153779Abutment for BridgesAltatec GmbH20161—
+6K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+6K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+6K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+6K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+6K151375Inclusive Titanium Abutments compatible with: Hiossen HG Implant SystemPrismatik Dentalcraft, Inc.20150—
+6K150295LOCATOR RTxZest Anchors, Inc.201542—
+6K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+6K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+6K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+6K142260NobelActiveNobel Biocare AB201599—
+6K142167Medentika Abutment SystemMedentika GmbH20157—
+6K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+6K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+6K141950HFD100 Rocker Arm AccessoryImris, Inc.20140—
+6K133991ISYAltatec GmbH20142—
+6K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+6K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+6K121810Osseospeed Angled Abutment EVAstra Tech AB20138—
+6K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+6K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+6K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+6K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+6K103280Bhdental Implant SystemBhdental, Ltd.20110—
+6K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd.20100—
+6K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+7K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+7K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+7K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+7K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+7K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+7K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+7K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+7K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+7K232383iPhysio® SystemEuroteknika20250—
+7K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+7K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+7K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+7K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+7K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+7K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+7K240143JDZygoma dental implantsJdentalcare Srl20240—
+7K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+7K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+7K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+7K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+7K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+7K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+7K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+7K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+7K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+7K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+7K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+7K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+7K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+7K220823Preat AbutmentsPreat Corporation202216
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+7K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+7K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+7K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+7K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+7K212538DESS Dental ImplantsTerrats Medical SL20211—
+7K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+7K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+7K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+7K193352AbutmentCADExocad GmbH20210—
+7K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+7K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+7K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—