510(k) Report

Devices descending from K081005

263 later devices reach P.004 NC Cares Titanium and Ceramic Abutments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150899Straumann CARES Titanium Alloy (TAN) AbutmentStraumann USA, LLC201511—
+1K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+1K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+1K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+1K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+1K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+1K093113Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG2009169—
+1K082545Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG2008171—
+2K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+2K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+2K212538DESS Dental ImplantsTerrats Medical SL20211—
+2K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+2K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+2K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+2K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+2K172798Straumann CARES Abutments CoCrInstitut Straumann AG20180—
+2K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+2K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+2K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+2K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+2K1514553Shape Abutment Designer Software3Shape A/S201610—
+2K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+2K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+2K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+2K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+2K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+2K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+2K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+2K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+2K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+2K133991ISYAltatec GmbH20142—
+2K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+2K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+2K131101Itero SoftwareCadent, Ltd. an Align Technology Company20130—
+2K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+2K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+2K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+2K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG2010167—
+3K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+3K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+3K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+3K251280DESS® Dental ImplantsTerrats Medical SL20250—
+3K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+3K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+3K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+3K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+3K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+3K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+3K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+3K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+3K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+3K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+3K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+3K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+3K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+3K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+3K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+3K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+3K193352AbutmentCADExocad GmbH20210—
+3K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+3K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+3K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+3K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+3K200100Abutment Design3Shape A/S20203—
+3K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+3K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+3K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+3K200355Duranext AbutmentsElegant Dental Corp.20200—
+3K191152MIS Ti-base AbutmentDentsply Sirona20201—
+3K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+3K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+3K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K183518Preat AbutmentsPreat Corporation2019223
+3K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+3K181932DTX Studio designNobel Biocare AB20190—
+3K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+3K181037DIO CAD/CAM AbutmentDio Corporation20187—
+3K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+3K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+3K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+3K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+3K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+3K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+3K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+3K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+3K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+3K162390ET Hybrid AbutmentHiossen, Inc.20172—
+3K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+3K160784CAM Titanium BlanksAltatec GmbH20161—
+3K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+3K151599iSy Implant SystemAltatec GmbH20150—
+3K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+3K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—