510(k) Report

Devices descending from K952811

464 later devices reach 3I Oral/Maxillofacial Bone Fixation System: Stainless Steel Bone-Mesh/Plate &… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K211872PiezoImplant SystemRex Implants, Inc.20220—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K213599SuperLineDentium Co., Ltd.20220—
+6K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+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—
+6K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+6K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+6K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+6K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+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—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+6K183518Preat AbutmentsPreat Corporation2019223
+6K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+6K173701Implant-One SystemImplant Logistics, Inc.20181—
+6K170732Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20180—
+6K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+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—
+6K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+6K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+6K171795Thommen Implant SystemThommen Medical AG20170—
+6K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+6K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+6K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+6K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+6K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+6K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+6K160786RODO Abutment SystemRodo Medical, Inc.20162—
+6K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+6K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+6K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+6K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+6K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+6K160213s-Clean Tapered II RBM Implant SystemDentis Co., Ltd.20160—
+6K160244VARIOuniteThommen Medical AG201615—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+6K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+6K153779Abutment for BridgesAltatec GmbH20161—
+6K1505713i T3 Short ImplantsBiomet 3i20151—
+6K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+6K150344Dentis Dental Implant SystemDentis Co., Ltd.201520—
+6K150295LOCATOR RTxZest Anchors, Inc.201542—
+6K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+6K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+6K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+6K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+6K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+6K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+6K133991ISYAltatec GmbH20142—
+6K133613Intra-Lock Dental ImplantsIntra-Lock International, Inc.20140—
+6K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+6K130140Intra-Lock OP Dental ImplantIntra-Lock International20131—
+6K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+6K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+6K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+6K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+6K111199Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled AbutmentsIntra-Lock International, Inc.20110—
+6K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+6K063106Revois Implant SystemCurasan AG20072—
+7K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+7K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+7K251427EK Multi Angled 30 AbutmentHiossen, Inc.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—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+7K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+7K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.20250—
+7K240383Highness Implant SystemHighness Co., Ltd.20240—
+7K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+7K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+7K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+7K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—