510(k) Report

Devices descending from K962014

493 later devices reach 3I Single Use, Disposable Drills,Taps,Burs, Etc. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+5K101545Genesis Implant SystemKeystone Dental2010153
+5K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+5K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+5K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+5K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+5K072595Omni-TightBasic Dental Implant Systems, Inc.20081—
+5K073486Dentis Dental Implant SystemDentis Co., Ltd.200825—
+5K061629Certain Prevail Dental ImplantImplant Innovations, Inc.20074—
+6K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+6K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+6K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+6K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K232383iPhysio® SystemEuroteknika20250—
+6K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K242261Accelx Implant SystemBiotech Dental, LLC20240—
+6K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+6K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+6K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+6K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+6K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+6K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K211872PiezoImplant SystemRex Implants, Inc.20220—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K213599SuperLineDentium Co., Ltd.20220—
+6K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+6K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+6K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+6K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+6K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+6K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+6K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+6K183518Preat AbutmentsPreat Corporation2019223
+6K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+6K173701Implant-One SystemImplant Logistics, Inc.20181—
+6K170732Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20180—
+6K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+6K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+6K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+6K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+6K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+6K171795Thommen Implant SystemThommen Medical AG20170—
+6K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+6K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+6K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+6K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+6K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+6K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+6K160786RODO Abutment SystemRodo Medical, Inc.20162—
+6K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+6K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+6K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+6K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+6K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+6K160213s-Clean Tapered II RBM Implant SystemDentis Co., Ltd.20160—
+6K160244VARIOuniteThommen Medical AG201615—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+6K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+6K153779Abutment for BridgesAltatec GmbH20161—
+6K1505713i T3 Short ImplantsBiomet 3i20151—
+6K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—