510(k) Report

Devices descending from K041492

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+5K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+5K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+5K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+5K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K190552JJ Implant SystemJj Implants20190—
+5K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+5K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+5K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+5K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+5K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+5K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+5K180609Rodo SmilekeyRodo Medical, Inc.20180—
+5K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+5K170394Kisses MiniAchimhai Medical Corporation20170—
+5K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+5K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+5K152555Dental Implant SystemAriabio International, Inc.20160—
+5K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+5K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+5K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K151599iSy Implant SystemAltatec GmbH20150—
+5K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+5K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+5K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+5K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+5K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+5K133362SGS Dental ImplantSgs International, Ltd.20142—
+5K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+5K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+5K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+6K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+6K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+6K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+6K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+6K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+6K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+6K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+6K231559Multi-Unit DAS SystemTalladium España, SL20231—
+6K232151Dynamic TiBaseTalladium España, SL20232—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K222636ET Abutment SystemHiossen, Inc.20230—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+6K220482SherlockOpen Implants, LLC20221—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K220022TRATE Dental Implant SystemTrate AG20221—
+6K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+6K213391High Retention Attachment SystemZest Anchors, LLC20227—
+6K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+6K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+6K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K191123Multi-unit AbutmentsMedentika GmbH202011—
+6K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+6K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+6K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+6K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+6K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—