510(k) Report

Devices descending from K941393

177 later devices reach Iti Angled Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+8K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+8K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+8K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+8K192742Straumann Variobase CInstitut Straumann AG20211—
+8K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+8K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+8K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+8K193335SherlockOpen Implants, LLC20203—
+8K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+8K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+8K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+8K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+8K171532TruBase STruabutment, Inc.20187—
+8K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+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—
+9K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+9K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+9K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+9K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+9K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+9K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+9K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+9K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+9K243009Mist ICImagine Milling Technologies, LLC20251—
+9K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+9K243824Preat AbutmentsPreat Corporation20250—
+9K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+9K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+9K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+9K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+9K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+9K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+9K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+9K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+9K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+9K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+9K212664SherlockOpen Implants, LLC20212—
+9K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+9K212108Dynamic TiBaseTalladium España, SL20219—
+9K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+9K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+10K261122Mist ICImagine Milling Technologies, LLC20260—
+10K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+10K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+10K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+10K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+10K221673Bonafix TiBaseZentek Medical, LLC20231—
+10K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+10K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+10K221966Dynamic TiBaseTalladium Espana, SL20225—
+10K220482SherlockOpen Implants, LLC20221—
+10K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+10K201842TruBase STruabutment, Inc.20210—
+11K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+11K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+11K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+11K250967SherlockOpen Implants, LLC20250—
+11K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+11K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+11K231559Multi-Unit DAS SystemTalladium España, SL20231—
+11K232151Dynamic TiBaseTalladium España, SL20232—
+11K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+11K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+12K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+12K243732Multi-Unit DAS SystemTalladium España, SL20260—
+12K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+12K243530Dynamic TiBaseTalladium España, SL20250—
+12K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+12K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+12K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+12K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+13K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+13K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+14K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—