510(k) Report

Devices descending from K061003

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+6K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+6K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+6K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+6K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+6K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+6K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+6K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+6K231559Multi-Unit DAS SystemTalladium España, SL20231—
+6K232151Dynamic TiBaseTalladium España, SL20232—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K221107TRUSTRgorithm Korea20230—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K222636ET Abutment SystemHiossen, Inc.20230—
+6K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+6K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K220482SherlockOpen Implants, LLC20221—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K213391High Retention Attachment SystemZest Anchors, LLC20227—
+6K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+6K211225MIS Ti-base abutmentDentsply Sirona20210—
+6K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+6K192742Straumann Variobase CInstitut Straumann AG20211—
+6K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+6K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+6K193404UF (II) Bar holder abutmentDio Corporation20200—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K171532TruBase STruabutment, Inc.20187—
+6K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+6K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+6K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+6K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+6K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+6K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+6K160784CAM Titanium BlanksAltatec GmbH20161—
+6K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K243732Multi-Unit DAS SystemTalladium España, SL20260—
+7K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+7K243530Dynamic TiBaseTalladium España, SL20250—
+7K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+7K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+7K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+7K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+7K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+7K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+7K223663SIMDA AbutmentSimda Co., Ltd.20232—
+7K222976MU SystemDentis Co., Ltd.20230—
+7K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+7K220252High Retention Attachment SystemZest Anchors, LLC20221—
+7K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+7K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+8K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+8K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+8K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+8K232271SIMDA abutmentSimda Co., Ltd.20230—
+8K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+8K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+8K201842TruBase STruabutment, Inc.20210—
+8K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+8K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+8K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+9K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+9K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+10K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—