510(k) Report

Devices descending from K905434

178 later devices reach Angulated Abutment, Complete,Titanium Sdca 102 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+7K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+7K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+7K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+7K220823Preat AbutmentsPreat Corporation202216
+7K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+7K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+7K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+7K193335SherlockOpen Implants, LLC20203—
+7K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+7K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+8K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+8K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K243824Preat AbutmentsPreat Corporation20250—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+8K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+8K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+8K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+8K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+8K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K212664SherlockOpen Implants, LLC20212—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+9K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+9K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+9K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+9K221673Bonafix TiBaseZentek Medical, LLC20231—
+9K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+9K221966Dynamic TiBaseTalladium Espana, SL20225—
+9K220482SherlockOpen Implants, LLC20221—
+9K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+9K201842TruBase STruabutment, Inc.20210—
+10K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+10K250967SherlockOpen Implants, LLC20250—
+10K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+10K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+10K231559Multi-Unit DAS SystemTalladium España, SL20231—
+10K232151Dynamic TiBaseTalladium España, SL20232—
+10K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+10K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+11K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+11K243732Multi-Unit DAS SystemTalladium España, SL20260—
+11K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+11K243530Dynamic TiBaseTalladium España, SL20250—
+11K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+11K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+11K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+11K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+12K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+12K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+13K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—