510(k) Report

Devices descending from K061003

507 later devices reach SFB & CFB Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K190552JJ Implant SystemJj Implants20190—
+3K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+3K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+3K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+3K183518Preat AbutmentsPreat Corporation2019223
+3K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+3K182293OsseOne Dental Implant SystemSynoross Dba Osseone20195—
+3K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+3K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+3K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+3K163349MIS V3 Conical Connection Dental Implant System­Mis Implants Technologies, Ltd.20178—
+3K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+3K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+3K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+3K161435Temporary Snap AbutmentNobel Biocare AB201601
+3K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+3K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+3K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+3K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+3K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+3K152555Dental Implant SystemAriabio International, Inc.20160—
+3K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+3K151916TRI Dental Implant SystemTri Dental Implants Int. AG20154—
+3K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+3K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+3K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+3K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+3K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+3K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+3K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+3K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+3K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+3K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+3K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+3K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+3K141450AXIOM 2.8Anthogyr Sas201401
+3K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+3K123861Aidi Dental Implant SystemAidi Biomedical, LLC20130—
+3K121873Avinent Dental Implant SystemAvinent Implant System S.L.20130—
+3K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+3K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+3K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+3K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+3K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+3K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20130—
+3K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+3K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+3K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+3K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+3K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—
+3K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+3K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.201216—
+3K113753Zimmer Dental Tapered Screw-Vent XZimmer Dental, Inc.20121—
+3K120414Osseospeed PlusAstra Tech AB2012196—
+3K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20121—
+3K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+3K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+3K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+3K112160Tapered Screw-Vent X ImplantZimmer Dental, Inc.20118819
+3K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+3K112259Nobelactive 3.0 Goldadapt AbutmentsNobel Biocare AB20110—
+3K111287Astra Tech Implant SystemAstra Tech AB2011201—
+3K110548Osi O-Ball Abutment Head ImplantsJuell Dental20112—
+3K11158115 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM…Nobel Biocare AB20114—
+3K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+3K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+3K081806Idi Implant SystemIdi Biomedical, LLC20082—
+4K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251280DESS® Dental ImplantsTerrats Medical SL20250—
+4K233271OsseOne Dental Implant SystemSynoross Dba Osseone20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K233896JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plusJdentalcare Srl20240—
+4K240837TOV Dental Implant SystemRdj Tov Implant, Ltd.20244—
+4K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+4K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—