510(k) Report

Devices descending from K954512

702 later devices reach Restore Self Tapping Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K121995TS Fixture SystemOsstem Implant Co., Ltd.201224—
+5K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+5K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+5K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+5K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+5K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+5K103537ET Iii SA Ultra Wide SystemHiossen, Inc.201137—
+5K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+6K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+6K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+6K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K253341Custom Abutments ASMedentika GmbH20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+6K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+6K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB20250—
+6K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+6K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+6K242379LL Implant SystemOssvis Co., Ltd.20240—
+6K242261Accelx Implant SystemBiotech Dental, LLC20240—
+6K240383Highness Implant SystemHighness Co., Ltd.20240—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+6K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+6K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+6K232528Protective CapNeobiotech Co., Ltd.20240—
+6K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+6K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+6K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+6K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+6K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+6K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+6K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+6K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+6K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+6K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+6K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+6K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K231079LW Retraction CapOssvis Co., Ltd.20230—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+6K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+6K221107TRUSTRgorithm Korea20230—
+6K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+6K222636ET Abutment SystemHiossen, Inc.20230—
+6K222738Point implant systemPointnix Co., Ltd.20230—
+6K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+6K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+6K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+6K213677Bonafix 2 PlusZentek Medical, LLC20220—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K213599SuperLineDentium Co., Ltd.20220—
+6K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+6K212664SherlockOpen Implants, LLC20212—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+6K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+6K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+6K211225MIS Ti-base abutmentDentsply Sirona20210—
+6K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+6K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+6K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+6K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+6K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+6K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+6K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—