510(k) Report

Devices descending from K061003

507 later devices reach SFB & CFB Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+4K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K220823Preat AbutmentsPreat Corporation202216
+4K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+4K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K213432MIS Angulated multi-unit abutmentsDentsply Sirona20220—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K213599SuperLineDentium Co., Ltd.20220—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+4K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+4K193335SherlockOpen Implants, LLC20203—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+4K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+4K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+4K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+4K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+4K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+4K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+4K181037DIO CAD/CAM AbutmentDio Corporation20187—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+4K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+4K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+4K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+4K173326MIS CONNECT Conical Connection AbutmentMis Implants Technologies, Ltd.20181—
+4K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+4K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd.20174—
+4K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+4K162390ET Hybrid AbutmentHiossen, Inc.20172—
+4K160786RODO Abutment SystemRodo Medical, Inc.20162—
+4K1514553Shape Abutment Designer Software3Shape A/S201610—
+4K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+4K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+4K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+4K160244VARIOuniteThommen Medical AG201615—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+4K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+4K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K150295LOCATOR RTxZest Anchors, Inc.201542—
+4K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+4K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+4K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+4K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+4K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+4K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+4K133991ISYAltatec GmbH20142—
+4K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+4K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+4K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+4K132258Zimmer Dental Trabecular Metal Implant SystemZimmer Dental, Inc.20130—
+4K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+4K123386Periotype X-PertClinical House Europe GmbH20131—
+4K121810Osseospeed Angled Abutment EVAstra Tech AB20138—
+4K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+4K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc.2011200—
+4K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+4K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+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—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K250872Bioline Dental Implant SystemBioline Dental Implant Systems, Ltd.20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K250176DAND Dental Implant SystemD.A.N.D. Metal Industries North, Ltd.20250—