510(k) Report

Devices descending from K033984

376 later devices reach Straumann Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+4K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+4K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+4K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+4K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+4K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+4K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+4K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+4K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+4K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+4K113606NNC Gold Abutment for BridgesStraumann USA20120—
+4K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+4K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K243278Custom AbutmentsInstitut Straumann AG202501
+5K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+5K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+5K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+5K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+5K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+5K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+5K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+5K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+5K212664SherlockOpen Implants, LLC20212—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+5K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+5K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+5K200355Duranext AbutmentsElegant Dental Corp.20200—
+5K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+5K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+5K181037DIO CAD/CAM AbutmentDio Corporation20187—
+5K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+5K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+5K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+5K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+5K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+5K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+5K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+5K162390ET Hybrid AbutmentHiossen, Inc.20172—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+5K160784CAM Titanium BlanksAltatec GmbH20161—
+5K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+5K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+5K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+5K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+5K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+5K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+5K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+6K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+6K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+6K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K233389EK Digital AbutmentsHiossen, Inc.20240—