510(k) Report

Devices descending from K072624

301 later devices reach Astra Tech Implant System, New Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+3K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+3K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+3K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+3K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+3K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+3K180609Rodo SmilekeyRodo Medical, Inc.20180—
+3K172100URIS OMNI SystemTruabutment, Inc.20187—
+3K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+3K170394Kisses MiniAchimhai Medical Corporation20170—
+3K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+3K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+3K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+3K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+3K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+3K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+3K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+3K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+3K151599iSy Implant SystemAltatec GmbH20150—
+3K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+3K140934Hiossen Implant SystemHiossen, Inc.201413—
+3K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+3K131165Anker Dental Implant SystemAlliance Global20131—
+3K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp.20130—
+3K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+3K121995TS Fixture SystemOsstem Implant Co., Ltd.201224—
+3K110308Prosthetic SystemOsstem Implant Co., Ltd.2011105—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+4K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K243824Preat AbutmentsPreat Corporation20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+4K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+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—
+4K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+4K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+4K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+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—
+4K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+4K231559Multi-Unit DAS SystemTalladium España, SL20231—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K232151Dynamic TiBaseTalladium España, SL20232—
+4K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+4K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+4K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222636ET Abutment SystemHiossen, Inc.20230—
+4K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222738Point implant systemPointnix Co., Ltd.20230—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+4K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+4K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+4K213391High Retention Attachment SystemZest Anchors, LLC20227—
+4K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+4K212664SherlockOpen Implants, LLC20212—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+4K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+4K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+4K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+4K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+4K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+4K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+4K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+4K153521IH Implant SystemSewonmedix, Inc.201610—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691