510(k) Report

Devices descending from K022113

463 later devices reach 3I Dental Implant Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K211872PiezoImplant SystemRex Implants, Inc.20220—
+5K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K213599SuperLineDentium Co., Ltd.20220—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+5K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+5K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+5K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+5K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+5K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+5K173701Implant-One SystemImplant Logistics, Inc.20181—
+5K170732Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20180—
+5K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+5K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+5K171795Thommen Implant SystemThommen Medical AG20170—
+5K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+5K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+5K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+5K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+5K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+5K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+5K160786RODO Abutment SystemRodo Medical, Inc.20162—
+5K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+5K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+5K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+5K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+5K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+5K160213s-Clean Tapered II RBM Implant SystemDentis Co., Ltd.20160—
+5K160244VARIOuniteThommen Medical AG201615—
+5K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+5K153779Abutment for BridgesAltatec GmbH20161—
+5K1505713i T3 Short ImplantsBiomet 3i20151—
+5K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+5K150344Dentis Dental Implant SystemDentis Co., Ltd.201520—
+5K150295LOCATOR RTxZest Anchors, Inc.201542—
+5K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+5K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+5K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+5K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+5K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+5K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+5K133991ISYAltatec GmbH20142—
+5K133613Intra-Lock Dental ImplantsIntra-Lock International, Inc.20140—
+5K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+5K130140Intra-Lock OP Dental ImplantIntra-Lock International20131—
+5K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+5K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+5K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K111199Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled AbutmentsIntra-Lock International, Inc.20110—
+5K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+5K063106Revois Implant SystemCurasan AG20072—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K253341Custom Abutments ASMedentika GmbH20250—
+6K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+6K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+6K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.20250—
+6K240383Highness Implant SystemHighness Co., Ltd.20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+6K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—