510(k) Report

Devices descending from K061003

507 later devices reach SFB & CFB Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131345Tiarray Dental Implant SystemNasseo, Inc.20130—
+1K072570Nobelactive Multi Unit AbutmentNobel Biocare AB20071811
+1K071370Nobelactive Internal Connection ImplantNobel Biocare AB20074144
+1K063718SFB and CFB Implants - 5.0 PlatformNobel Biocare AB20070—
+1K062936Nobelperfect Conical ConnectionNobel Biocare AB20061—
+1K062566Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC200610927
+1K062749SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model…Nobel Biocare AB2006327—
+2K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+2K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+2K212394Implant-One Multi-Unit AbutmentImplant Logistics, Inc.20230—
+2K220339Esthetic Abutments Nobel Biocare N1Nobel Biocare Services AG20220—
+2K200193Kisses Plus Implant SystemAchimhai Medical Corporation20210—
+2K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+2K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+2K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+2K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+2K170372SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc.20178—
+2K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+2K161416Multi-unit Abutment PlusNobel Biocare AB201774—
+2K1516084plus6Line Abutment SystemOt Medical GmbH20160—
+2K143142JDENTALCARE Implant SystemJdentalcare Srl20152—
+2K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+2K150968TRU Dental Implant SystemSterngold Dental, LLC20150—
+2K142260NobelActiveNobel Biocare AB201599—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K133362SGS Dental ImplantSgs International, Ltd.20142—
+2K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+2K130694JR Implant SystemLK Consulting Group USA, Inc.20140—
+2K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+2K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc.201414—
+2K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+2K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+2K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+2K120776Abutment for Competitive Implant Nobel Active ConnectionBiomet 3i20120—
+2K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+2K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+2K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG201264—
+2K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+2K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+2K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC20114—
+2K103280Bhdental Implant SystemBhdental, Ltd.20110—
+2K101732Astra Tech Implant SystemAstra Tech AB2011214—
+2K102436Nobel Active 3.0Nobel Biocare AB2010203—
+2K101755Aidi Dental Implant SystemAidi Biomedical, LLC20101—
+2K101545Genesis Implant SystemKeystone Dental2010153
+2K101880Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc.2010941
+2K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+2K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+2K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100—
+2K093483Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini +…Astra Tech, Inc.200967—
+2K091756Nobelprocera TI AbutmentNobel Biocare AB2009278—
+2K083192Inclusive Titanium Abutment BlanksInclusive Dental Solutions200940—
+2K083205Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB2009103—
+2K083100Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RPNobel Biocare USA, LLC20081—
+2K081128Molar ImplantNobel Biocare AB20080—
+2K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+2K072129Nobelactive Zirconia AbutmentNobel Biocare AB200871—
+2K073142Nobelreplace Hexagonal ImplantNobel Biocare USA, LLC2008952
+2K072980Nobelperfect Conical Connection Hexagonal ImplantsNobel Biocare AB20070—
+2K070533Bti Endosseous Dental Implant Angled AbutmentsB.T.I. Biotechnology Institute, Sl.20070—
+3K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+3K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K242064Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20251—
+3K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+3K240383Highness Implant SystemHighness Co., Ltd.20240—
+3K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+3K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+3K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+3K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB20242—
+3K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+3K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+3K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+3K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+3K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+3K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+3K221381KDG AbutmentsKeystone Dental, Inc.20220—
+3K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+3K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+3K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+3K212538DESS Dental ImplantsTerrats Medical SL20211—
+3K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+3K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+3K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+3K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+3K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+3K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+3K200329IDCAM Dental ImplantsImplants Diffusion International20210—
+3K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+3K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+3K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+3K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+3K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+3K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+3K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+3K200355Duranext AbutmentsElegant Dental Corp.20200—
+3K182081JDentalCare Implant System JDIconJdentalcare Srl20201—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K200188DSI Dental Implant SystemDsi Dental Solutions, Ltd.20200—