510(k) Report

Devices descending from K083550

228 later devices reach Straumann Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+1K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+1K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+1K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+1K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+1K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA2012123—
+1K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+1K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+1K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+2K231566ICX-Implant SystemMedentis Medical GmbH20240—
+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
+2K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+2K212538DESS Dental ImplantsTerrats Medical SL20211—
+2K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+2K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+2K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+2K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+2K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+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—
+2K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+2K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+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—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+2K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+2K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+2K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+2K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+2K113606NNC Gold Abutment for BridgesStraumann USA20120—
+2K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+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—
+3K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+3K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+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—
+3K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+3K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+3K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+3K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+3K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+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—
+3K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+3K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+3K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+3K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+3K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+3K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+3K200355Duranext AbutmentsElegant Dental Corp.20200—
+3K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+3K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K183518Preat AbutmentsPreat Corporation2019223
+3K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+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—
+3K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+3K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+3K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+3K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+3K162390ET Hybrid AbutmentHiossen, Inc.20172—
+3K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+3K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+3K160784CAM Titanium BlanksAltatec GmbH20161—
+3K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+3K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+3K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+3K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+4K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253341Custom Abutments ASMedentika GmbH20250—