510(k) Report

Devices descending from K041492

360 later devices reach Astra Tech Implants - Dental System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073075Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant SystemsDentsply International, Inc.2008304—
+1K043195Neo Implant SystemNeoss, Ltd.2005167—
+2K211396Neoss Individual ProstheticsNeoss, Ltd.20220—
+2K180282MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd.201811—
+2K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+2K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+2K150669Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)Neoss, Ltd.201514—
+2K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K131066Axiom RegAnthogyr Sas20142—
+2K120954Nobelprocera Peek AbutmentsNobel Biocare AB2013105—
+2K122268Angled Xive MP Abutment, Angled AnkylosDentsply International20122—
+2K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+2K093780Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini +…Astra Tech, Inc.2010200—
+2K090452Neoss Implant System 03.25Neoss, Ltd.20093—
+2K083805Ankylos C/X Dental Implant SystemDentsply Intl., Inc.2009290—
+2K083561Neoss Proactive ImplantNeoss, Ltd.20095—
+2K071838Neoss Various Titanium AbutmentsNeoss, Ltd.200774—
+3K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+3K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+3K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+3K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+3K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+3K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+3K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+3K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+3K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+3K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+3K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+3K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+3K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+3K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+3K200102MIS Dental Implant SystemDentsply Sirona20200—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+3K192149MIS Dental Implant SystemDentsply Sirona, Inc.20191—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K183518Preat AbutmentsPreat Corporation2019223
+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—
+3K173701Implant-One SystemImplant Logistics, Inc.20181—
+3K172160Southern Implants PEEK AbutmentsSouthern Implants (Pty), Ltd.20182—
+3K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+3K161177Axiom PXAnthogyr Sas20170—
+3K161435Temporary Snap AbutmentNobel Biocare AB201601
+3K151757IMMEDIATELOAD Dental Implant SystemImmediateload S.A.20160—
+3K151588maxFit II Dental Implant SystemTaiwan Implant Technology Company, Ltd.20160—
+3K141188Microdent Genius Implant SystemImplant Microdent20150—
+3K141450AXIOM 2.8Anthogyr Sas201401
+3K140347Ankylos C/X Implant SystemDentsply Intl., Inc.20146—
+3K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+3K131644Ankylos Syncone Abutment 5(Degree)Dentsply International, Inc.20141—
+3K113376Neoss Proactive Tapered ImplantNeoss, Ltd.20120—
+3K120414Osseospeed PlusAstra Tech AB2012196—
+3K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+3K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+3K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+3K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+4K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+4K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+4K220823Preat AbutmentsPreat Corporation202216
+4K213599SuperLineDentium Co., Ltd.20220—
+4K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+4K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+4K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+4K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—