510(k) Report

Devices descending from K945847

570 later devices reach Frialit (R)-2 Stepped Screw with Deep Profile Surface through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+8K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+8K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+8K220482SherlockOpen Implants, LLC20221—
+8K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+8K213391High Retention Attachment SystemZest Anchors, LLC20227—
+8K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+8K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+8K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+8K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+8K192742Straumann Variobase CInstitut Straumann AG20211—
+8K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+8K191123Multi-unit AbutmentsMedentika GmbH202011—
+8K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+8K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+8K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+8K171532TruBase STruabutment, Inc.20187—
+8K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+8K170421ET Hybrid AbutmentHiossen, Inc.20180—
+8K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+8K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+8K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+9K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+9K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+9K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+9K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+9K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+9K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+9K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+9K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+9K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+9K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+9K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+9K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+9K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+9K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+9K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+9K232271SIMDA abutmentSimda Co., Ltd.20230—
+9K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+9K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+9K222976MU SystemDentis Co., Ltd.20230—
+9K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+9K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+9K220252High Retention Attachment SystemZest Anchors, LLC20221—
+9K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+9K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+9K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+9K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+10K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+10K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+10K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+10K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+10K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+10K201842TruBase STruabutment, Inc.20210—
+11K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+11K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+11K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+11K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+11K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+12K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+12K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+12K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+12K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+13K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—