510(k) Report

Devices descending from K960288

512 later devices reach HA & TPS Restore Self Tapping Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K220022TRATE Dental Implant SystemTrate AG20221—
+6K213599SuperLineDentium Co., Ltd.20220—
+6K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+6K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+6K212664SherlockOpen Implants, LLC20212—
+6K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+6K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+6K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+6K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+6K200386Z5-BLZ-Systems AG20200—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+6K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+6K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K191123Multi-unit AbutmentsMedentika GmbH202011—
+6K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+6K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+6K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+6K172100URIS OMNI SystemTruabutment, Inc.20187—
+6K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+6K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+6K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+6K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+6K153521IH Implant SystemSewonmedix, Inc.201610—
+6K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+6K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+6K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+6K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+6K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+6K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+6K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+6K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+6K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+6K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+6K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+6K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+6K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+6K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+6K113606NNC Gold Abutment for BridgesStraumann USA20120—
+6K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+6K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+7K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+7K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+7K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+7K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+7K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+7K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+7K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+7K240143JDZygoma dental implantsJdentalcare Srl20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+7K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+7K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+7K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+7K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+7K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+7K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+7K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K222707IH Implant SystemSewonmedix, Inc.20231—
+7K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+7K222976MU SystemDentis Co., Ltd.20230—
+7K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+7K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220482SherlockOpen Implants, LLC20221—