510(k) Report

Devices descending from K984104

1,043 later devices reach Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K083805Ankylos C/X Dental Implant SystemDentsply Intl., Inc.2009290—
+5K081101Spectra-System Abutments 2008Implant Direct, LLC200911—
+5K081128Molar ImplantNobel Biocare AB20080—
+5K081579Inventus Implant SystemInventus Co., Ltd.20080—
+5K081575HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd.2008129—
+5K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+5K073465US/GS Ultra Wide SystemOsstem Implant Co., Ltd.200890—
+5K070184Dental Implant, Dental Abutment, Abutment Screw, Cover Screw, Healing AbutmentOspol AB20081—
+5K080387HU II / HS II Fixture SystemOsstem Implant Co., Ltd.200877—
+5K073247US/SS/GS SystemOsstem Implant Co., Ltd.2008141—
+5K073067Ankylos Dental Implant System/ClaimsDentsply International, Inc.20080—
+5K063861GS SystemOsstem Implant Co., Ltd.2007202—
+5K062936Nobelperfect Conical ConnectionNobel Biocare AB20061—
+5K062566Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC200610927
+5K061477Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant SystemsNobel Biocare AB200666—
+5K061003SFB & CFB ImplantsNobel Biocare AB2006507—
+5K040170Friadent Plus Dental Implant SystemsFriadent GmbH200484—
+6K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+6K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+6K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsParagon Implant Mfg., LLC20250—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+6K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+6K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+6K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC20251—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K243278Custom AbutmentsInstitut Straumann AG202501
+6K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+6K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+6K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.20250—
+6K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+6K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+6K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+6K232528Protective CapNeobiotech Co., Ltd.20240—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB20242—
+6K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+6K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+6K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+6K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+6K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K231079LW Retraction CapOssvis Co., Ltd.20230—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+6K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K222707IH Implant SystemSewonmedix, Inc.20231—
+6K222142BR SLA Type Implant SystemBiotem Co., Ltd.20230—
+6K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+6K222144IR SLA Type Implant SystemBiotem Co., Ltd.20230—
+6K222636ET Abutment SystemHiossen, Inc.20230—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+6K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+6K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+6K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+6K210039CORE1 Implant SystemCybermed, Inc.20220—
+6K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122