510(k) Report

Devices descending from K972351

548 later devices reach Sendax Mdi (Mini Dental Implant) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+6K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+6K202790Syntec Orthodontic Mini Screw Extended SystemSyntec Scientific Corporation20210—
+6K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+6K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+6K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+6K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+6K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+6K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+6K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+6K200102MIS Dental Implant SystemDentsply Sirona20200—
+6K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K190871Bio-TackS Orthodontic Mini ImplantBiocetec Co., Ltd.20200—
+6K192149MIS Dental Implant SystemDentsply Sirona, Inc.20191—
+6K191201EM SA Implant SystemHiossen, Inc.20191—
+6K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+6K182929BIO-RAY A-1 Anchor Screw SystemMicroware Precision Co., Ltd.20190—
+6K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+6K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+6K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+6K183518Preat AbutmentsPreat Corporation2019223
+6K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+6K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+6K173701Implant-One SystemImplant Logistics, Inc.20181—
+6K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+6K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+6K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+6K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+6K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+6K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+6K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+6K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+6K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+6K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+6K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+6K160786RODO Abutment SystemRodo Medical, Inc.20162—
+6K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+6K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+6K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+6K160244VARIOuniteThommen Medical AG201615—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+6K153779Abutment for BridgesAltatec GmbH20161—
+6K152297OBS Anchorage ScrewBomei Co, Ltd.20161—
+6K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+6K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+6K1505713i T3 Short ImplantsBiomet 3i20151—
+6K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+6K150295LOCATOR RTxZest Anchors, Inc.201542—
+6K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+6K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+6K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+6K142001Syntec Wetali Orthodontic Mini ScrewsSyntec Scientific Corporation - Taipei Office20151—
+6K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+6K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+6K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+6K133991ISYAltatec GmbH20142—
+6K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+6K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+6K133613Intra-Lock Dental ImplantsIntra-Lock International, Inc.20140—
+6K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+6K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+6K121117NDX AbutmentsNational Dentex Corp20120—
+6K120271Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20120—
+6K110392PSM Lomas / Benefit ScrewsPsm Medical Solutions20115—
+6K111199Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled AbutmentsIntra-Lock International, Inc.20110—
+6K063106Revois Implant SystemCurasan AG20072—
+7K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K253341Custom Abutments ASMedentika GmbH20250—
+7K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+7K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+7K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A.20250—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+7K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+7K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+7K242379LL Implant SystemOssvis Co., Ltd.20240—
+7K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+7K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—