510(k) Report

Devices descending from K023067

321 later devices reach Imtec Sendax Mdi ORTHO6 and ORTHO8 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+4K143022BioHorizons Tapered Internal ImplantsBioHorizons Implant Systems, Inc.20154—
+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—
+4K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+4K122171MS SA Implant SystemOsstem Implant Co., Ltd.20122—
+4K111120CSM Submerged-R Implant SystemCsm Implant20118—
+4K101913Anthofit OI, Anthofit HE, Ossfit and AxiomAnthogyr Sas201131
+4K103020Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc.20114—
+4K101545Genesis Implant SystemKeystone Dental2010153
+4K100985Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc.201073—
+4K081226Simpact Implant SystemSimpact, LLC20081—
+4K073032Primaconnex SD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc.20070—
+4K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc.20077—
+4K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc.20066—
+4K053643Stage- 1 Temporary/Healing Cap, Model 42021-42026Lifecore Biomedical, Inc.20060—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+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—
+5K230630ZENEX Implant System_NarrowIzenimplant Co., Ltd.20230—
+5K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+5K230246Dentis s-Clean SQ-SL Narrow Implant SystemDentis Co., Ltd.20230—
+5K222636ET Abutment SystemHiossen, Inc.20230—
+5K220079Magicore Narrow SystemInnobiosurg Co., Ltd.20220—
+5K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+5K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+5K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+5K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+5K191201EM SA Implant SystemHiossen, Inc.20191—
+5K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+5K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+5K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+5K161177Axiom PXAnthogyr Sas20170—
+5K170211Insight Dental SystemInsight Dental System20170—
+5K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+5K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+5K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K141450AXIOM 2.8Anthogyr Sas201401
+5K131066Axiom RegAnthogyr Sas20142—
+5K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+5K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+5K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+5K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+5K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+5K083141Simpact Endosseous Dental Implant SystemSimpact, LLC20080—
+6K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+6K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+6K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+6K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+6K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K242379LL Implant SystemOssvis Co., Ltd.20240—
+6K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240383Highness Implant SystemHighness Co., Ltd.20240—
+6K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—