510(k) Report

Devices descending from K041661

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+3K142260NobelActiveNobel Biocare AB201599—
+3K142167Medentika Abutment SystemMedentika GmbH20157—
+3K142082Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour AbutementZimmer Dental, Inc.20140—
+3K141450AXIOM 2.8Anthogyr Sas201401
+3K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+3K130694JR Implant SystemLK Consulting Group USA, Inc.20140—
+3K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+3K133339Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M…Zimmer Dental, Inc.20143—
+3K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+3K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+3K131644Ankylos Syncone Abutment 5(Degree)Dentsply International, Inc.20141—
+3K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+3K132258Zimmer Dental Trabecular Metal Implant SystemZimmer Dental, Inc.20130—
+3K131345Tiarray Dental Implant SystemNasseo, Inc.20130—
+3K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+3K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+3K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+3K113753Zimmer Dental Tapered Screw-Vent XZimmer Dental, Inc.20121—
+3K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+3K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+3K112160Tapered Screw-Vent X ImplantZimmer Dental, Inc.20118819
+3K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+3K110577Osseofuse Dental Implant SystemDynamic Innovations, Inc.20114—
+3K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+3K101880Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc.2010941
+3K101068Accufit Dental Implant Abutments & ScrewsRadiant Express, LLC20100—
+3K073142Nobelreplace Hexagonal ImplantNobel Biocare USA, LLC2008952
+3K072570Nobelactive Multi Unit AbutmentNobel Biocare AB20071811
+3K072980Nobelperfect Conical Connection Hexagonal ImplantsNobel Biocare AB20070—
+3K072589Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11…Zimmer Dental, Inc.2007983
+3K071370Nobelactive Internal Connection ImplantNobel Biocare AB20074144
+3K063718SFB and CFB Implants - 5.0 PlatformNobel Biocare AB20070—
+3K062749SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model…Nobel Biocare AB2006327—
+4K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+4K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+4K251280DESS® Dental ImplantsTerrats Medical SL20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+4K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+4K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+4K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+4K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+4K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+4K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+4K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+4K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+4K230103Klockner AbutmentsSoadco, S.L.20230—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K212394Implant-One Multi-Unit AbutmentImplant Logistics, Inc.20230—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K220823Preat AbutmentsPreat Corporation202216
+4K220339Esthetic Abutments Nobel Biocare N1Nobel Biocare Services AG20220—
+4K220978TSX ImplantsBiomet 3i, LLC20221—
+4K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+4K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+4K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+4K200193Kisses Plus Implant SystemAchimhai Medical Corporation20210—
+4K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+4K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+4K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+4K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+4K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+4K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+4K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+4K193335SherlockOpen Implants, LLC20203—
+4K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K190552JJ Implant SystemJj Implants20190—