510(k) Report

Devices descending from K924830

226 later devices reach Luxatemp Automix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223663SIMDA AbutmentSimda Co., Ltd.20232—
+6K222489Harvest Printable ResinHarvest Dental Products, LLC20230—
+6K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+6K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+6K222623Digital CrownSprintray, Inc.20224—
+6K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+6K222061Dental LT Clear V2 ResinFormlabs Ohio, Inc.20221—
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K220771Stratasys TrueDentStratasys, Ltd.202215
+6K212017Thermeo SystemPro3Dure Medical GmbH20221—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K211415GR Splint Resin SystemPro3Dure Medical GmbH20212—
+6K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+6K210940LuxaPrint Ortho PlusDmg Digital Enterprises SE20210—
+6K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+6K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K192742Straumann Variobase CInstitut Straumann AG20211—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K183518Preat AbutmentsPreat Corporation2019223
+6K171532TruBase STruabutment, Inc.20187—
+6K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+6K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+6K170421ET Hybrid AbutmentHiossen, Inc.20180—
+6K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K260031Thermeo® I MsiPro3Dure Medical GmbH20260—
+7K260152Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.20260—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K260661Midas RestoreSprintray, Inc.20260—
+7K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+7K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+7K242277Crown HTSprintray, Inc.20241—
+7K231566ICX-Implant SystemMedentis Medical GmbH20240—
+7K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K232087Dental LT Comfort ResinFormlabs Ohio, Inc.20240—
+7K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+7K232271SIMDA abutmentSimda Co., Ltd.20230—
+7K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+7K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+7K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+7K220823Preat AbutmentsPreat Corporation202216
+7K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+7K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+7K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+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—
+7K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+7K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+7K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+7K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+8K261246SRGC-06GC America, Inc.20260—
+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—
+8K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+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—
+8K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+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—
+8K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+8K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+8K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+8K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+8K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+8K212664SherlockOpen Implants, LLC20212—
+8K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+8K201842TruBase STruabutment, Inc.20210—
+8K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+9K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+9K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+9K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+9K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+9K221673Bonafix TiBaseZentek Medical, LLC20231—