510(k) Report

Devices descending from K945847

570 later devices reach Frialit (R)-2 Stepped Screw with Deep Profile Surface through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+6K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+6K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+6K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+6K183079Conometric AbutmentsDentsply Sirona, Inc.20190—
+6K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+6K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+6K181932DTX Studio designNobel Biocare AB20190—
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+6K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+6K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+6K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+6K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+6K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+6K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+6K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd.20174—
+6K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+6K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+6K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+6K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+6K161177Axiom PXAnthogyr Sas20170—
+6K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+6K160786RODO Abutment SystemRodo Medical, Inc.20162—
+6K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+6K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+6K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+6K160244VARIOuniteThommen Medical AG201615—
+6K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+6K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+6K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+6K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+6K151599iSy Implant SystemAltatec GmbH20150—
+6K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+6K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+6K150295LOCATOR RTxZest Anchors, Inc.201542—
+6K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+6K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+6K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+6K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+6K141450AXIOM 2.8Anthogyr Sas201401
+6K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+6K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+6K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+6K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+6K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+6K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+6K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+6K113779Conelog Implant SystemAltatec GmbH201214—
+6K121334VarioecoThommen Medical AG201216—
+6K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+6K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+7K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+7K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+7K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+7K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+7K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+7K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+7K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+7K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+7K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20242—
+7K240143JDZygoma dental implantsJdentalcare Srl20240—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+7K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+7K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+7K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+7K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+7K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+7K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—