510(k) Report

Devices descending from K022859

520 later devices reach Abutment and Prosthetic Accessories to the Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+4K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+4K093027Straumann RC Temporary AbutmentsStraumann USA201097—
+4K072679P.004 AbutmentsInstitut Straumann AG2007279—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+5K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+5K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+5K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+5K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K233389EK Digital AbutmentsHiossen, Inc.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+5K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+5K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+5K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K220823Preat AbutmentsPreat Corporation202216
+5K221966Dynamic TiBaseTalladium Espana, SL20225—
+5K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+5K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+5K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+5K212538DESS Dental ImplantsTerrats Medical SL20211—
+5K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+5K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+5K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+5K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+5K200355Duranext AbutmentsElegant Dental Corp.20200—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K193335SherlockOpen Implants, LLC20203—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+5K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+5K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+5K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+5K181037DIO CAD/CAM AbutmentDio Corporation20187—
+5K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+5K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+5K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+5K180609Rodo SmilekeyRodo Medical, Inc.20180—
+5K172100URIS OMNI SystemTruabutment, Inc.20187—
+5K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+5K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+5K170421ET Hybrid AbutmentHiossen, Inc.20180—
+5K170080Neodent Implant System - CM Pro PEEK AbutmentJjgc Industria E Comercio DE Materiais Dentarios S.A.20170—
+5K170394Kisses MiniAchimhai Medical Corporation20170—
+5K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+5K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+5K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+5K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+5K160784CAM Titanium BlanksAltatec GmbH20161—
+5K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+5K1514553Shape Abutment Designer Software3Shape A/S201610—
+5K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+5K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+5K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+5K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+5K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+5K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+5K151599iSy Implant SystemAltatec GmbH20150—
+5K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+5K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+5K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+5K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+5K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+5K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+5K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+5K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—