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
+1K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007187—
+1K051576Avana Dental Implant SystemOsstem Co., Ltd.2005222—
+2K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+2K162299Spiral Shape Dental Implant SystemGp Implants20173—
+2K150363NOVA Dental Implants SystemNova Implants, Ltd.20150—
+2K133362SGS Dental ImplantSgs International, Ltd.20142—
+2K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+2K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+2K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+2K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+2K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+2K103280Bhdental Implant SystemBhdental, Ltd.20110—
+2K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+2K081748Oneplant Dental Implant SystemWarantec Co., Ltd.20099—
+2K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+2K071803Ards Dental ImplantsArds, Ltd.200813—
+2K073116Ebi Internal Implant SystemEbi, Inc.20083—
+2K062030US SystemOsstem Implant Co., Ltd.2006183—
+2K062051SS SystemOsstem Implant Co., Ltd.2006211—
+3K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+3K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+3K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+3K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+3K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+3K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+3K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+3K172100URIS OMNI SystemTruabutment, Inc.20187—
+3K171179BR Type Implant SystemBiotem Co., Ltd.20181—
+3K172240SPI Dental Implant SystemMsi France20180—
+3K171185IR Type Implant SystemBiotem Co., Ltd.20171—
+3K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+3K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+3K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+3K170031Internal Octa Implant SystemEbi, Inc.20171—
+3K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+3K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+3K152555Dental Implant SystemAriabio International, Inc.20160—
+3K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+3K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+3K142426EBI External Implant SystemEbi, Inc.20150—
+3K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+3K140051KJ External Implant SystemKj Meditech Co., Ltd.20140—
+3K140052J2I Implant SystemKj Meditech Co., Ltd.20140—
+3K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+3K131701Z5MLB, Z5MLCZ-Systems AG20131—
+3K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+3K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+3K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+3K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+3K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+3K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+3K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+3K090527Sinus Quick IT SystemNeobiotech Co., Ltd.20097—
+3K081579Inventus Implant SystemInventus Co., Ltd.20080—
+3K081575HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd.2008129—
+3K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+3K073465US/GS Ultra Wide SystemOsstem Implant Co., Ltd.200890—
+3K080387HU II / HS II Fixture SystemOsstem Implant Co., Ltd.200877—
+3K073247US/SS/GS SystemOsstem Implant Co., Ltd.2008141—
+3K063861GS SystemOsstem Implant Co., Ltd.2007202—
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K222142BR SLA Type Implant SystemBiotem Co., Ltd.20230—
+4K222144IR SLA Type Implant SystemBiotem Co., Ltd.20230—
+4K222636ET Abutment SystemHiossen, Inc.20230—
+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
+4K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+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—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—