510(k) Report

Devices descending from K894595

1,051 later devices reach Bonefit R Screw Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB20242—
+7K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+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—
+7K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+7K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+7K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K222707IH Implant SystemSewonmedix, Inc.20231—
+7K222142BR SLA Type Implant SystemBiotem Co., Ltd.20230—
+7K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+7K222144IR SLA Type Implant SystemBiotem Co., Ltd.20230—
+7K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+7K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+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—
+7K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+7K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+7K220482SherlockOpen Implants, LLC20221—
+7K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+7K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+7K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+7K210039CORE1 Implant SystemCybermed, Inc.20220—
+7K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+7K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+7K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+7K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+7K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+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—
+7K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+7K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+7K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+7K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+7K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+7K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+7K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+7K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+7K190837Internal Hex Implant SystemEbi, Inc.20200—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+7K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K181137IT-III active SystemNeobiotech Co., Ltd.20183—
+7K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+7K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+7K180609Rodo SmilekeyRodo Medical, Inc.20180—
+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—
+7K170394Kisses MiniAchimhai Medical Corporation20170—
+7K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+7K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+7K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+7K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+7K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+7K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+7K162390ET Hybrid AbutmentHiossen, Inc.20172—
+7K161435Temporary Snap AbutmentNobel Biocare AB201601
+7K160784CAM Titanium BlanksAltatec GmbH20161—
+7K1514553Shape Abutment Designer Software3Shape A/S201610—
+7K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+7K151757IMMEDIATELOAD Dental Implant SystemImmediateload S.A.20160—
+7K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+7K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+7K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+7K151588maxFit II Dental Implant SystemTaiwan Implant Technology Company, Ltd.20160—
+7K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+7K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+7K152520Magicore SystemInnobiosurg Co., Ltd.20167—
+7K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+7K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+7K151599iSy Implant SystemAltatec GmbH20150—
+7K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+7K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+7K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+7K142260NobelActiveNobel Biocare AB201599—
+7K140347Ankylos C/X Implant SystemDentsply Intl., Inc.20146—
+7K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+7K130694JR Implant SystemLK Consulting Group USA, Inc.20140—
+7K132956U Fit Dental Implant SystemT Strong, Inc.20141—
+7K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+7K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+7K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+7K131345Tiarray Dental Implant SystemNasseo, Inc.20130—
+7K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+7K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp.20130—
+7K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—