510(k) Report

Devices descending from K952811

464 later devices reach 3I Oral/Maxillofacial Bone Fixation System: Stainless Steel Bone-Mesh/Plate &… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+5K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+5K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K213677Bonafix 2 PlusZentek Medical, LLC20220—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+5K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+5K200386Z5-BLZ-Systems AG20200—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K190919ST Internal Implant SystemT-Plus Implant Tech. Co., Ltd.20200—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+5K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+5K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc.20160—
+5K160119NobelSpeedy GroovyNobel Biocare AB20167—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+5K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+5K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+5K142174Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20151—
+5K142167Medentika Abutment SystemMedentika GmbH20157—
+5K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+5K140934Hiossen Implant SystemHiossen, Inc.201413—
+5K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+5K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+5K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+5K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+5K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+5K123870Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd.20131—
+5K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+5K113779Conelog Implant SystemAltatec GmbH201214—
+5K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+5K120414Osseospeed PlusAstra Tech AB2012196—
+5K120043CSM Internal-R Implant SystemCsm Implant20121—
+5K110337Universal Maxillary MolarOco Biomedical20121—
+5K110955Anyridge Internal Implant SystemMegagen Co., Ltd.201143—
+5K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc.201121—
+5K103194Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc.20115—
+5K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB201118—
+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—
+6K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+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—
+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—
+6K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+6K232383iPhysio® SystemEuroteknika20250—
+6K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K242261Accelx Implant SystemBiotech Dental, LLC20240—
+6K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+6K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+6K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+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—
+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—