510(k) Report

Devices descending from K020646

630 later devices reach Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+5K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+5K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+5K171795Thommen Implant SystemThommen Medical AG20170—
+5K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+5K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+5K161177Axiom PXAnthogyr Sas20170—
+5K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+5K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+5K161435Temporary Snap AbutmentNobel Biocare AB201601
+5K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+5K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+5K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+5K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+5K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+5K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+5K151928PUR Dental Implant SystemSterngold Dental, LLC20150—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+5K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+5K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+5K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+5K142260NobelActiveNobel Biocare AB201599—
+5K142082Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour AbutementZimmer Dental, Inc.20140—
+5K141450AXIOM 2.8Anthogyr Sas201401
+5K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+5K130694JR Implant SystemLK Consulting Group USA, Inc.20140—
+5K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+5K133339Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M…Zimmer Dental, Inc.20143—
+5K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+5K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+5K131644Ankylos Syncone Abutment 5(Degree)Dentsply International, Inc.20141—
+5K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+5K132258Zimmer Dental Trabecular Metal Implant SystemZimmer Dental, Inc.20130—
+5K131345Tiarray Dental Implant SystemNasseo, Inc.20130—
+5K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+5K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+5K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+5K113753Zimmer Dental Tapered Screw-Vent XZimmer Dental, Inc.20121—
+5K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K112160Tapered Screw-Vent X ImplantZimmer Dental, Inc.20118819
+5K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+5K110577Osseofuse Dental Implant SystemDynamic Innovations, Inc.20114—
+5K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+5K101880Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc.2010941
+5K101068Accufit Dental Implant Abutments & ScrewsRadiant Express, LLC20100—
+5K073142Nobelreplace Hexagonal ImplantNobel Biocare USA, LLC2008952
+5K072570Nobelactive Multi Unit AbutmentNobel Biocare AB20071811
+5K072980Nobelperfect Conical Connection Hexagonal ImplantsNobel Biocare AB20070—
+5K072589Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11…Zimmer Dental, Inc.2007983
+5K071370Nobelactive Internal Connection ImplantNobel Biocare AB20074144
+5K063718SFB and CFB Implants - 5.0 PlatformNobel Biocare AB20070—
+5K062749SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model…Nobel Biocare AB2006327—
+6K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K232383iPhysio® SystemEuroteknika20250—
+6K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+6K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+6K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+6K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+6K231566ICX-Implant SystemMedentis Medical GmbH20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+6K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+6K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+6K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+6K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+6K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+6K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+6K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+6K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+6K230103Klockner AbutmentsSoadco, S.L.20230—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K212394Implant-One Multi-Unit AbutmentImplant Logistics, Inc.20230—
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K220823Preat AbutmentsPreat Corporation202216
+6K220339Esthetic Abutments Nobel Biocare N1Nobel Biocare Services AG20220—
+6K220978TSX ImplantsBiomet 3i, LLC20221—
+6K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+6K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+6K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+6K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—