510(k) Report

Devices descending from K894593

536 later devices reach Bonefit Hollow Cylinder Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240143JDZygoma dental implantsJdentalcare Srl20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+7K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+7K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+7K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+7K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+7K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+7K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+7K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K222707IH Implant SystemSewonmedix, Inc.20231—
+7K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+7K222976MU SystemDentis Co., Ltd.20230—
+7K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+7K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220482SherlockOpen Implants, LLC20221—
+7K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+7K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+7K210039CORE1 Implant SystemCybermed, Inc.20220—
+7K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+7K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+7K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+7K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+7K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+7K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+7K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+7K200355Duranext AbutmentsElegant Dental Corp.20200—
+7K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+7K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+7K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K181037DIO CAD/CAM AbutmentDio Corporation20187—
+7K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+7K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+7K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+7K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+7K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+7K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+7K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+7K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+7K162390ET Hybrid AbutmentHiossen, Inc.20172—
+7K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+7K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+7K160784CAM Titanium BlanksAltatec GmbH20161—
+7K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+7K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+7K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+7K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+7K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+7K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+7K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+8K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+8K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+8K240977DenQ Sub SLA Implant SystemDenq20240—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K233389EK Digital AbutmentsHiossen, Inc.20240—
+8K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+8K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+8K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+8K223663SIMDA AbutmentSimda Co., Ltd.20232—
+8K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+8K220517IBS SystemInnobiosurg Co., Ltd.20220—
+8K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+8K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+8K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+8K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+8K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+8K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+8K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+8K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+8K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+8K192742Straumann Variobase CInstitut Straumann AG20211—
+8K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+8K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+8K171532TruBase STruabutment, Inc.20187—