510(k) Report

Devices descending from K974738

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120414Osseospeed PlusAstra Tech AB2012196—
+1K101005Astra Tech Implant System, New ComponentAstra Tech AB2011198—
+1K071838Neoss Various Titanium AbutmentsNeoss, Ltd.200774—
+1K043195Neo Implant SystemNeoss, Ltd.2005167—
+1K024111Astra Tech Implants-Dental System Fixture OsseospeedAstra Tech, Inc.2003423—
+1K023631Astra Tech Dental Implants-Ceramic AbutmentsAstra Tech, Inc.2002307—
+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—
+2K211396Neoss Individual ProstheticsNeoss, Ltd.20220—
+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—
+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
+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—
+2K160786RODO Abutment SystemRodo Medical, Inc.20162—
+2K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+2K160244VARIOuniteThommen Medical AG201615—
+2K150669Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)Neoss, Ltd.201514—
+2K150040ImplanovaDental Evolutions, Inc.20150—
+2K150295LOCATOR RTxZest Anchors, Inc.201542—
+2K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K133991ISYAltatec GmbH20142—
+2K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+2K120954Nobelprocera Peek AbutmentsNobel Biocare AB2013105—
+2K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+2K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+2K083670Universal, Aesthetica, Natea, NaturaEuroteknika20090—
+2K090452Neoss Implant System 03.25Neoss, Ltd.20093—
+2K083561Neoss Proactive ImplantNeoss, Ltd.20095—
+2K081786Ziocera & Convertible SystemOsstem Implant Co., Ltd.2008123—
+2K071946Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsAtlantis Components, Inc.2007209—
+2K070833Atlantis Abutment for Astra ImplantAtlantis Components, Inc.2007357—
+2K061567Biohorizons Ceramic AbutmentBioHorizons Implant Systems, Inc.20060—
+2K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc.20066—
+2K060958Straumann Narrow Neck ImplantsStraumann USA2006228—
+2K051501ZiraceAcucera, Inc.20058—
+2K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC200432—
+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—
+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—
+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—
+3K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+3K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.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—
+3K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+3K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+3K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—