510(k) Report

Devices descending from K022562

929 later devices reach Various Branemark System Implants-Immediate Function Indication through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+3K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253341Custom Abutments ASMedentika GmbH20250—
+3K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+3K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+3K242072CeraRoot TL Implant System (TL)Ceraroot SL20250—
+3K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+3K232383iPhysio® SystemEuroteknika20250—
+3K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+3K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+3K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+3K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+3K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+3K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+3K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+3K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+3K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+3K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+3K222368Mist ICImagine Milling Technologies, LLC20222—
+3K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+3K220823Preat AbutmentsPreat Corporation202216
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+3K211396Neoss Individual ProstheticsNeoss, Ltd.20220—
+3K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+3K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+3K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+3K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+3K201712Z5-TLZ-Systems AG20200—
+3K200386Z5-BLZ-Systems AG20200—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K200102MIS Dental Implant SystemDentsply Sirona20200—
+3K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+3K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K193335SherlockOpen Implants, LLC20203—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K190243Z5-BLZ-Systems AG20202—
+3K192149MIS Dental Implant SystemDentsply Sirona, Inc.20191—
+3K191054Southern Implants MAX Implant SystemSouthern Implants (Pty), Ltd.20191—
+3K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+3K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+3K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+3K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+3K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+3K173701Implant-One SystemImplant Logistics, Inc.20181—
+3K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+3K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K173575OsteoReady Dental Implant SystemOsteoready, LLC20180—
+3K180598UNIQA Dental Implants SystemUniqa Dental, Ltd.20181—
+3K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+3K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K170131TAV Medical Dental Implants SystemTav Medical, Ltd.20181—
+3K172240SPI Dental Implant SystemMsi France20180—
+3K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+3K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+3K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+3K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+3K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+3K162853Bonafix TWO - Dental Implant SystemBonafix Surgical and Dental Implants20170—
+3K161177Axiom PXAnthogyr Sas20170—
+3K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+3K161593GMI Frontier Dental Implant SystemIlerimplant S.L20170—
+3K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+3K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+3K151757IMMEDIATELOAD Dental Implant SystemImmediateload S.A.20160—
+3K152787ST Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20162—
+3K152786A Plus Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20160—
+3K160119NobelSpeedy GroovyNobel Biocare AB20167—
+3K153036NobelDesign SoftwareNobel Biocare AB20161—
+3K151588maxFit II Dental Implant SystemTaiwan Implant Technology Company, Ltd.20160—
+3K151439Atlantis IsusDentsply International, Inc.20160—
+3K152555Dental Implant SystemAriabio International, Inc.20160—
+3K151328PURE Ceramic ImplantsStraumann USA201612—
+3K150669Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)Neoss, Ltd.201514—
+3K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+3K150021Z5m (t)Z-Systems AG20150—
+3K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+3K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+3K142751Chang Gung ComMed Series Dental Implant SystemChang Gung Medical Technology Co., Ltd.20150—
+3K141188Microdent Genius Implant SystemImplant Microdent20150—
+3K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+3K142426EBI External Implant SystemEbi, Inc.20150—
+3K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+3K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+3K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+3K141450AXIOM 2.8Anthogyr Sas201401
+3K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+3K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+3K140347Ankylos C/X Implant SystemDentsply Intl., Inc.20146—
+3K133255Zeramex T and Zeramex Plus Dental Implant SystemsDentalpoint AG20143—
+3K132749Nobelprocera Overdenture BarNobel Biocare USA, LLC20140—
+3K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+3K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+3K131644Ankylos Syncone Abutment 5(Degree)Dentsply International, Inc.20141—
+3K132992TI Star Implant SystemT-Plus Implant Tech. Co., Ltd.20133—
+3K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+3K131701Z5MLB, Z5MLCZ-Systems AG20131—