510(k) Report

Devices descending from K091239

228 later devices reach Astra Tech Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112787KeratorKj Meditech Co., Ltd.20123—
+1K120414Osseospeed PlusAstra Tech AB2012196—
+1K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+1K111287Astra Tech Implant SystemAstra Tech AB2011201—
+1K103280Bhdental Implant SystemBhdental, Ltd.20110—
+1K101732Astra Tech Implant SystemAstra Tech AB2011214—
+2K241183ISO AbutmentSeum Medi Co., 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—
+2K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+2K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+2K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+2K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+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
+2K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+2K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+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—
+2K163349MIS V3 Conical Connection Dental Implant System­Mis Implants Technologies, Ltd.20178—
+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—
+2K160786RODO Abutment SystemRodo Medical, Inc.20162—
+2K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+2K160244VARIOuniteThommen Medical AG201615—
+2K150295LOCATOR RTxZest Anchors, Inc.201542—
+2K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K133991ISYAltatec GmbH20142—
+2K132144KeratorLK Consulting Group USA, Inc.20140—
+2K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+2K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+2K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+2K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20130—
+2K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+2K121810Osseospeed Angled Abutment EVAstra Tech AB20138—
+2K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20121—
+2K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc.2011200—
+3K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+3K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+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—
+3K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.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—
+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—
+3K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+3K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+3K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+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—
+3K213432MIS Angulated multi-unit abutmentsDentsply Sirona20220—
+3K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+3K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+3K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+3K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+3K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+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—
+3K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K193335SherlockOpen Implants, LLC20203—
+3K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+3K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+3K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+3K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+3K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+3K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—