510(k) Report

Devices descending from K935544

601 later devices reach 3I Standard Threaded/Self-Tapping Threaded Implants Modification through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+5K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+5K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+5K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+5K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+5K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+5K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+5K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+5K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc.2011200—
+5K110356Atlantis Crown Abutment, Atlantis Gemini +(TM) AbutmentAstra Tech, Inc.2011202—
+5K103759Atlantis Abutment in Zirconia for Osseospeed TX Profile ImplantAstra Tech, Inc.201119—
+5K100993Inclusive Titanium Abutments for Astra Tech Osseospeed ImplantsPrismatik Dentalcraft, Inc.201033—
+5K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+5K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+6K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+6K243732Multi-Unit DAS SystemTalladium España, SL20260—
+6K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+6K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+6K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K243530Dynamic TiBaseTalladium España, SL20250—
+6K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.20250—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K240383Highness Implant SystemHighness Co., Ltd.20240—
+6K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+6K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+6K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+6K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+6K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K222976MU SystemDentis Co., Ltd.20230—
+6K220482SherlockOpen Implants, LLC20221—
+6K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K220252High Retention Attachment SystemZest Anchors, LLC20221—
+6K210039CORE1 Implant SystemCybermed, Inc.20220—
+6K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+6K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+6K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+6K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+6K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+6K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+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—
+6K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+6K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+6K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+6K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+6K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+6K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+6K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+6K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+6K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+6K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+6K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+6K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+6K1514553Shape Abutment Designer Software3Shape A/S201610—
+6K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+6K151375Inclusive Titanium Abutments compatible with: Hiossen HG Implant SystemPrismatik Dentalcraft, Inc.20150—
+6K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+6K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+6K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+6K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+6K121810Osseospeed Angled Abutment EVAstra Tech AB20138—
+6K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+6K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+6K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+7K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+7K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+7K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+7K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+7K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+7K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301