510(k) Report

Devices descending from K041661

622 later devices reach Nobel Biocare Endosseous Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+4K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+4K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K173701Implant-One SystemImplant Logistics, Inc.20181—
+4K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+4K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+4K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+4K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+4K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+4K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+4K170372SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc.20178—
+4K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K161416Multi-unit Abutment PlusNobel Biocare AB201774—
+4K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+4K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+4K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K1516084plus6Line Abutment SystemOt Medical GmbH20160—
+4K151439Atlantis IsusDentsply International, Inc.20160—
+4K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+4K151916TRI Dental Implant SystemTri Dental Implants Int. AG20154—
+4K143142JDENTALCARE Implant SystemJdentalcare Srl20152—
+4K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+4K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+4K150968TRU Dental Implant SystemSterngold Dental, LLC20150—
+4K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+4K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+4K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+4K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+4K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K133050One Plus Implant SystemOsseofuse, Inc.20141—
+4K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+4K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+4K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+4K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc.201414—
+4K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+4K131748Osseofuse Dental Implant SystemOsseofuse, Inc.20130—
+4K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+4K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+4K130221Hero II Dental Implant System, UI Dental Implant SystemMedimecca Co., Ltd.20130—
+4K120776Abutment for Competitive Implant Nobel Active ConnectionBiomet 3i20120—
+4K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+4K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG201264—
+4K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+4K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC20114—
+4K103280Bhdental Implant SystemBhdental, Ltd.20110—
+4K101732Astra Tech Implant SystemAstra Tech AB2011214—
+4K102436Nobel Active 3.0Nobel Biocare AB2010203—
+4K101755Aidi Dental Implant SystemAidi Biomedical, LLC20101—
+4K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+4K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+4K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100—
+4K093483Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini +…Astra Tech, Inc.200967—
+4K091756Nobelprocera TI AbutmentNobel Biocare AB2009278—
+4K083192Inclusive Titanium Abutment BlanksInclusive Dental Solutions200940—
+4K083205Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB2009103—
+4K083100Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RPNobel Biocare USA, LLC20081—
+4K081806Idi Implant SystemIdi Biomedical, LLC20082—
+4K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+4K072129Nobelactive Zirconia AbutmentNobel Biocare AB200871—
+4K070533Bti Endosseous Dental Implant Angled AbutmentsB.T.I. Biotechnology Institute, Sl.20070—
+5K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+5K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+5K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K253341Custom Abutments ASMedentika GmbH20250—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+5K242064Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20251—
+5K240383Highness Implant SystemHighness Co., Ltd.20240—
+5K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+5K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+5K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB20242—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+5K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+5K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—