510(k) Report

Devices descending from K002188

395 later devices reach Swissplus Implant System, Model SPWB 8,10,12,14/OPH20/SMPR, SPB… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+4K200386Z5-BLZ-Systems AG20200—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+4K190837Internal Hex Implant SystemEbi, Inc.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—
+4K181137IT-III active SystemNeobiotech Co., Ltd.20183—
+4K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+4K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+4K153521IH Implant SystemSewonmedix, Inc.201610—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K152520Magicore SystemInnobiosurg Co., Ltd.20167—
+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—
+4K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+4K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+4K132956U Fit Dental Implant SystemT Strong, Inc.20141—
+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—
+4K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp.20130—
+4K121843NP-Cast Abutment SystemOsstem Implant Co., Ltd.201254—
+4K120847ET/SS Implant SystemOsstem Implant Co., Ltd.201275—
+4K120043CSM Internal-R Implant SystemCsm Implant20121—
+4K110308Prosthetic SystemOsstem Implant Co., Ltd.2011105—
+4K103537ET Iii SA Ultra Wide SystemHiossen, Inc.201137—
+4K101890Ball Abutment SystemMegagen Co., Ltd.20110—
+4K100245HS/HG Prosthetic SystemOsstem Implant Co., Ltd.2010111—
+4K100511Cotec Dental Implant SystemCotec Implant Co., Ltd.20100—
+4K093889Modification to: HG Iii Ultra Wide SystemHiossen, Inc.201038—
+4K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+4K090825SQ IS SystemNeobiotech Co., Ltd.200955—
+4K082843Modificaton to: Dentis Dental Implant SystemDentis Co., Ltd.20091—
+4K083633HS II Short Fixture SystemOsstem Implant Co., Ltd.200976—
+4K081786Ziocera & Convertible SystemOsstem Implant Co., Ltd.2008123—
+4K080744HG II Fixture SystemOsstem Implant Co., Ltd.2008112—
+4K072896GS Fixture SystemOsstem Implant Co., Ltd.200715—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+5K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+5K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+5K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+5K222707IH Implant SystemSewonmedix, Inc.20231—
+5K222792SNUCONE Tissue Level Implant SystemSnucone Co., Ltd.20232—
+5K221752StellaShinhung Mst Co., Ltd.20230—
+5K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+5K222976MU SystemDentis Co., Ltd.20230—
+5K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K201981Magicore SystemInnobiosurg Co., Ltd.20204—
+5K190637Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd.20200—
+5K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+5K192197Magicore II SystemInnobiosurg Co., Ltd.20203—
+5K192263UCLA CCM AbutmentDio Corporation20204—
+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—
+5K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+5K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+5K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+5K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+5K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+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—
+5K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+5K140934Hiossen Implant SystemHiossen, Inc.201413—
+5K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+5K123627ET Smartfit AbutmentHiossen, Inc.201321—
+5K123755Multi Angled AbutmentOsstem Implant Co., Ltd.201347—
+5K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+5K121995TS Fixture SystemOsstem Implant Co., Ltd.201224—
+5K121047Hero II Dental Implant System, IS Dental Implant SystemKj Meditech Co., Ltd.201214—
+5K120951Smartbuilder SystemOsstem Implant Co., Ltd.201214—
+5K113554Cmi Implant IS SystemNeobiotech Co., Ltd.201234—