510(k) Report

Devices descending from K053088

295 later devices reach Slactive Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+5K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K223663SIMDA AbutmentSimda Co., Ltd.20232—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+5K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+5K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+5K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+5K212664SherlockOpen Implants, LLC20212—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+5K192742Straumann Variobase CInstitut Straumann AG20211—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+5K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+5K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+5K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+5K171532TruBase STruabutment, Inc.20187—
+5K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+5K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+5K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K170421ET Hybrid AbutmentHiossen, Inc.20180—
+5K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+5K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+5K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+5K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+6K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+6K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+6K232271SIMDA abutmentSimda Co., Ltd.20230—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K220482SherlockOpen Implants, LLC20221—
+6K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+6K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+6K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+6K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+6K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K231559Multi-Unit DAS SystemTalladium España, SL20231—
+7K232151Dynamic TiBaseTalladium España, SL20232—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+7K201842TruBase STruabutment, Inc.20210—
+8K243732Multi-Unit DAS SystemTalladium España, SL20260—
+8K243530Dynamic TiBaseTalladium España, SL20250—
+8K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+8K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+8K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+8K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+8K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+9K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+9K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+9K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+9K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—