510(k) Report

Devices descending from K061809

212 later devices reach Artegral Imcrown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K210940LuxaPrint Ortho PlusDmg Digital Enterprises SE20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K192742Straumann Variobase CInstitut Straumann AG20211—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K171532TruBase STruabutment, Inc.20187—
+5K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+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—
+6K260031Thermeo® I MsiPro3Dure Medical GmbH20260—
+6K260152Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.20260—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K260661Midas RestoreSprintray, Inc.20260—
+6K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K242277Crown HTSprintray, Inc.20241—
+6K231566ICX-Implant SystemMedentis Medical GmbH20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K232087Dental LT Comfort ResinFormlabs Ohio, Inc.20240—
+6K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+6K232271SIMDA abutmentSimda Co., Ltd.20230—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K220823Preat AbutmentsPreat Corporation202216
+6K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+6K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+6K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K193335SherlockOpen Implants, LLC20203—
+6K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+6K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K261246SRGC-06GC America, Inc.20260—
+7K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+7K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+7K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+7K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+7K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+7K212664SherlockOpen Implants, LLC20212—
+7K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+7K212108Dynamic TiBaseTalladium España, SL20219—
+7K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+7K201842TruBase STruabutment, Inc.20210—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+8K261122Mist ICImagine Milling Technologies, LLC20260—
+8K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+8K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+8K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+8K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+8K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+8K221673Bonafix TiBaseZentek Medical, LLC20231—
+8K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+8K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+8K221966Dynamic TiBaseTalladium Espana, SL20225—
+8K220482SherlockOpen Implants, LLC20221—
+8K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+9K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+9K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+9K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+9K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+9K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+9K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+9K231559Multi-Unit DAS SystemTalladium España, SL20231—