510(k) Report

Devices descending from K023067

321 later devices reach Imtec Sendax Mdi ORTHO6 and ORTHO8 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+6K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+6K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+6K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+6K222976MU SystemDentis Co., Ltd.20230—
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+6K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+6K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+6K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+6K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K183518Preat AbutmentsPreat Corporation2019223
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+6K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+6K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+6K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+6K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+6K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+6K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+6K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+6K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+6K121117NDX AbutmentsNational Dentex Corp20120—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K220517IBS SystemInnobiosurg Co., Ltd.20220—
+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—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+7K220823Preat AbutmentsPreat Corporation202216
+7K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+7K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+7K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+7K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+7K193335SherlockOpen Implants, LLC20203—
+7K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+7K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+7K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+8K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K243824Preat AbutmentsPreat Corporation20250—
+8K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+8K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+8K212664SherlockOpen Implants, LLC20212—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+8K171795Thommen Implant SystemThommen Medical AG20170—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—