510(k) Report

Devices descending from K022113

463 later devices reach 3I Dental Implant Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+4K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+4K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+4K240143JDZygoma dental implantsJdentalcare Srl20240—
+4K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K213677Bonafix 2 PlusZentek Medical, LLC20220—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+4K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+4K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K200386Z5-BLZ-Systems AG20200—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K190919ST Internal Implant SystemT-Plus Implant Tech. Co., Ltd.20200—
+4K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+4K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc.20160—
+4K160119NobelSpeedy GroovyNobel Biocare AB20167—
+4K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+4K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+4K142174Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20151—
+4K142167Medentika Abutment SystemMedentika GmbH20157—
+4K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+4K140934Hiossen Implant SystemHiossen, Inc.201413—
+4K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+4K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+4K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+4K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+4K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+4K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+4K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+4K123870Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd.20131—
+4K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+4K113779Conelog Implant SystemAltatec GmbH201214—
+4K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+4K120414Osseospeed PlusAstra Tech AB2012196—
+4K120043CSM Internal-R Implant SystemCsm Implant20121—
+4K110337Universal Maxillary MolarOco Biomedical20121—
+4K110955Anyridge Internal Implant SystemMegagen Co., Ltd.201143—
+4K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc.201121—
+4K103194Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc.20115—
+4K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB201118—
+4K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+4K101545Genesis Implant SystemKeystone Dental2010153
+4K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+4K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+4K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+4K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+4K072595Omni-TightBasic Dental Implant Systems, Inc.20081—
+4K073486Dentis Dental Implant SystemDentis Co., Ltd.200825—
+4K061629Certain Prevail Dental ImplantImplant Innovations, Inc.20074—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+5K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+5K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K242261Accelx Implant SystemBiotech Dental, LLC20240—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+5K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+5K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+5K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—