510(k) Report

Devices descending from K062129

434 later devices reach P.0004 Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190048UF (II) Anatomic abutmentDio Corporation20190—
+1K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+1K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+1K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+1K143539Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH20158—
+1K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+1K142167Medentika Abutment SystemMedentika GmbH20157—
+1K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+1K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+1K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+1K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+1K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+1K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+1K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+1K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+1K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC20114—
+1K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+1K091701Straumann Modified Dental AbutmentInstitut Straumann AG200911—
+1K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+1K083192Inclusive Titanium Abutment BlanksInclusive Dental Solutions200940—
+1K083550Straumann Dental Implant SystemStraumann USA2009228—
+1K071888Straumann P.004 RC Gold Abutment for BridgesStraumann USA20071—
+1K072679P.004 AbutmentsInstitut Straumann AG2007279—
+1K072497P.004 NC Gold Abutment for CrownsInstitut Straumann AG2007224—
+1K071919P.004 AbutmentsStraumann USA (On Behalf of Institut Straumann Ag)20070—
+1K071357P.004 NC Anatomic AbutmentsInstitut Straumann AG2007114—
+1K070478P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc.2007283—
+1K072151P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA20072641
+1K070549Straumann P.004 RC Gold AbutmentInstitut Straumann AG2007225—
+1K072071Straumann P.004 Cementable Abutments, Temporary Copings and Protective CapsInstitut Straumann AG2007205—
+1K071585P.004 Healing Abutments and Closure ScrewsStraumann USA20072331
+2K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+2K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+2K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+2K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+2K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+2K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+2K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+2K231566ICX-Implant SystemMedentis Medical GmbH20240—
+2K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+2K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+2K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+2K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+2K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+2K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+2K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+2K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+2K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+2K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+2K212538DESS Dental ImplantsTerrats Medical SL20211—
+2K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+2K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+2K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+2K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+2K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+2K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+2K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+2K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+2K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+2K182246Mist ICImagine Milling Technologies, LLC20194—
+2K183518Preat AbutmentsPreat Corporation2019223
+2K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+2K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+2K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+2K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+2K173819MyPlant II Implant SystemHager& Meisinger GmbH20183—
+2K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+2K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+2K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+2K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+2K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+2K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+2K162073Dental Implants OKTAGON Tissue Level and Bone LevelHager& Meisinger GmbH20170—
+2K160132Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone…Hager& Meisinger GmbH20160—
+2K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+2K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+2K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+2K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+2K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+2K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+2K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+2K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+2K150899Straumann CARES Titanium Alloy (TAN) AbutmentStraumann USA, LLC201511—
+2K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+2K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+2K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+2K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+2K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+2K133991ISYAltatec GmbH20142—
+2K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+2K132214Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator…Hager& Meisinger GmbH20149—
+2K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+2K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+2K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+2K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+2K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+2K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+2K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+2K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+2K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA2012123—