510(k) Report

Devices descending from K000018

263 later devices reach Branemark Novum through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152836TREFOIL SystemNobel Biocare AB20162—
+1K030685Teeth in an Hour - Ark Implant ConceptNobel Biocare AB20042591
+2K172352TREFOIL SystemNobel Biocare AB20170—
+2K170135TREFOIL SystemNobel Biocare AB20170—
+2K053602Procera Software, Model 33145Nobel Biocare AB2006248—
+2K050393The Guided Surgery ConceptNobel Biocare AB2005258—
+3K153036NobelDesign SoftwareNobel Biocare AB20161—
+3K123976NobelclinicianNobel Biocare AB20133—
+3K113739Simplant Immediate Smile Dental Care SystemMaterialise Dental NV20123—
+3K112679Simplant Navigator Personalized Dental Care SystemMaterialise Dental NV20120—
+3K093113Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG2009169—
+3K062493Lava Software3M Espe AG Dental Products2006242—
+4K171466NobelDesign, DTX Studio DesignNobel Biocare AB20170—
+4K170849SIMPLANT GuideDentsply Sirona20172—
+4K163122NobelClinician, DTX Studio implantNobel Biocare AB20172—
+4K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+4K131101Itero SoftwareCadent, Ltd. an Align Technology Company20130—
+4K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+4K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG2010167—
+4K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+5K231898DTX Studio Clinic (4.0)Nobel Biocare AB20231—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K193405Simplant Digital GuideDentsply Sirona20200—
+5K190059CEREC GuidesDentsply Sirona20190—
+5K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+5K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+5K1514553Shape Abutment Designer Software3Shape A/S201610—
+5K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+5K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+5K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+5K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+5K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+5K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+5K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+5K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+5K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+5K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+5K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+5K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+6K252086DTX Studio AssistNobel Biocare C/O Medicim NV20250—
+6K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+6K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+6K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+6K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+6K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+6K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+6K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+6K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K193352AbutmentCADExocad GmbH20210—
+6K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+6K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+6K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+6K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+6K200100Abutment Design3Shape A/S20203—
+6K200355Duranext AbutmentsElegant Dental Corp.20200—
+6K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+6K183518Preat AbutmentsPreat Corporation2019223
+6K181932DTX Studio designNobel Biocare AB20190—
+6K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+6K181037DIO CAD/CAM AbutmentDio Corporation20187—
+6K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+6K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+6K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+6K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+6K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+6K171795Thommen Implant SystemThommen Medical AG20170—
+6K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+6K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+6K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+6K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+6K162390ET Hybrid AbutmentHiossen, Inc.20172—
+6K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+6K160784CAM Titanium BlanksAltatec GmbH20161—
+6K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+6K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+6K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+6K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+6K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+6K133991ISYAltatec GmbH20142—
+6K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+6K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+6K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+6K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+7K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+7K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+7K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+7K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+7K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K232383iPhysio® SystemEuroteknika20250—
+7K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+7K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+7K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+7K231566ICX-Implant SystemMedentis Medical GmbH20240—
+7K233389EK Digital AbutmentsHiossen, Inc.20240—
+7K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—