510(k) Report

Devices descending from K013570

495 later devices reach Osseotite Dental Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+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—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K211872PiezoImplant SystemRex Implants, Inc.20220—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K213599SuperLineDentium Co., Ltd.20220—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+4K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+4K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+4K200102MIS Dental Implant SystemDentsply Sirona20200—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+4K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+4K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K173701Implant-One SystemImplant Logistics, Inc.20181—
+4K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+4K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+4K172240SPI Dental Implant SystemMsi France20180—
+4K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+4K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+4K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+4K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+4K160786RODO Abutment SystemRodo Medical, Inc.20162—
+4K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+4K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K152787ST Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20162—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K152786A Plus Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20160—
+4K160244VARIOuniteThommen Medical AG201615—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K153779Abutment for BridgesAltatec GmbH20161—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K1505713i T3 Short ImplantsBiomet 3i20151—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+4K150295LOCATOR RTxZest Anchors, Inc.201542—
+4K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+4K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+4K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+4K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+4K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+4K133991ISYAltatec GmbH20142—
+4K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+4K132992TI Star Implant SystemT-Plus Implant Tech. Co., Ltd.20133—
+4K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+4K131701Z5MLB, Z5MLCZ-Systems AG20131—
+4K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+4K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+4K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+4K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+4K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+4K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—