510(k) Report

Devices descending from K080396

390 later devices reach Osseospeed Narrow through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140293Touareg NP Closefit Dental Implants SystemAdin Dental Implants Systems, Ltd.20142—
+1K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+1K120414Osseospeed PlusAstra Tech AB2012196—
+1K112875Blue Sky Bio Dental Taper Hex Implant SystemsBlue Sky Bio, LLC20120—
+1K101005Astra Tech Implant System, New ComponentAstra Tech AB2011198—
+1K093321Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc.20101031
+1K092555Uno Narrow ImplantMis Implants Technologies, Ltd.201036—
+1K092112Bti Dental Implant Tiny 2.5-3.0B.T.I. Biotechnology Institute, Sl.20096—
+1K083544Kat Implant SystemKat Implants, LLC20094—
+1K081666Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 ImplantsAstra Tech, Inc.2008337—
+2K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+2K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+2K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+2K213599SuperLineDentium Co., Ltd.20220—
+2K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+2K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+2K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+2K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+2K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+2K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+2K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+2K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+2K183518Preat AbutmentsPreat Corporation2019223
+2K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+2K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+2K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+2K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+2K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+2K171795Thommen Implant SystemThommen Medical AG20170—
+2K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+2K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+2K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+2K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+2K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd.201620—
+2K160786RODO Abutment SystemRodo Medical, Inc.20162—
+2K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+2K160244VARIOuniteThommen Medical AG201615—
+2K153111TOUAREG CloseFit™ UNP 2.75mmDAdin Dental Implants Systems, Ltd.20161—
+2K151391BTI Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20165—
+2K150040ImplanovaDental Evolutions, Inc.20150—
+2K150295LOCATOR RTxZest Anchors, Inc.201542—
+2K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+2K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K143022BioHorizons Tapered Internal ImplantsBioHorizons Implant Systems, Inc.20154—
+2K133362SGS Dental ImplantSgs International, Ltd.20142—
+2K133991ISYAltatec GmbH20142—
+2K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+2K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+2K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+2K112758Kat Implants System One-Piece Implants 2.5X10Kat Implants, LLC20120—
+2K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+2K111120CSM Submerged-R Implant SystemCsm Implant20118—
+2K101201Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0 Model…Kat Implants, LLC20113—
+2K100993Inclusive Titanium Abutments for Astra Tech Osseospeed ImplantsPrismatik Dentalcraft, Inc.201033—
+2K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+2K100985Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc.201073—
+3K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+3K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+3K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+3K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+3K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+3K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+3K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+3K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+3K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+3K233137Ticare Dental Implant SystemsMozograu S.A.20240—
+3K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+3K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+3K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+3K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+3K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+3K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+3K230630ZENEX Implant System_NarrowIzenimplant Co., Ltd.20230—
+3K230246Dentis s-Clean SQ-SL Narrow Implant SystemDentis Co., Ltd.20230—
+3K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+3K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+3K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+3K220079Magicore Narrow SystemInnobiosurg Co., Ltd.20220—
+3K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+3K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+3K220823Preat AbutmentsPreat Corporation202216
+3K221966Dynamic TiBaseTalladium Espana, SL20225—
+3K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+3K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+3K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+3K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+3K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+3K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+3K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+3K202825BTI Extra-Short Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20210—
+3K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+3K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+3K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—