510(k) Report

Devices descending from K041368

98 later devices reach Dentium CO., LTD. Implantium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141457Dentium Implantium and Superline AbutmentsDentium Co., Ltd.20146—
+1K131165Anker Dental Implant SystemAlliance Global20131—
+1K123155Luna Dental Implant SystemShinhung Mst Co., Ltd.20136—
+1K111189Syntec Dental ImplantSyntec Scientific Corp.20120—
+1K110425HC-Bios Dental ImplantHung Chun Bio-S Co., Ltd.20121—
+1K112045Simpleline II Abutment SystemDentium Co., Ltd.201260—
+1K081748Oneplant Dental Implant SystemWarantec Co., Ltd.20099—
+1K052957Implantium ProstheticsDentium Co., Ltd.200678—
+1K060501Implantium IIDentium Co., Ltd.200626—
+1K052823Implantium AbutmentsDentium, Inc.200621—
+2K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+2K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+2K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+2K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+2K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+2K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+2K221752StellaShinhung Mst Co., Ltd.20230—
+2K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+2K200193Kisses Plus Implant SystemAchimhai Medical Corporation20210—
+2K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+2K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+2K192436Healing Abutments and Cover ScrewsDentium Co., Ltd.20205—
+2K172345IU Implant SystemWarantec Co., Ltd.20182—
+2K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+2K172100URIS OMNI SystemTruabutment, Inc.20187—
+2K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+2K160828Dentium Implantium & SuperLine ProstheticsDentium Co., Ltd.20160—
+2K160483Burn-out Cylinder and Angled Screw AbutmentsDentium Co., Ltd.20160—
+2K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+2K132956U Fit Dental Implant SystemT Strong, Inc.20141—
+2K132242Inno Sla Submerged Implant SystemCowellmedi Co., Ltd.20133—
+2K122519Dio UF Hsa Internal Sub-Merged Implant SystemDio Corporation201312—
+2K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+2K121843NP-Cast Abutment SystemOsstem Implant Co., Ltd.201254—
+2K103280Bhdental Implant SystemBhdental, Ltd.20110—
+2K102308Simpleline II Model SOFX483408R, SOFX483410R Total 44 ModelsDentium Co., Ltd.20100—
+2K070228Implantium ProstheticsDentium Co., Ltd.200763—
+3K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+3K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+3K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+3K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+3K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+3K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+3K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+3K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+3K221969IU Implant System AbutmentWarantec Co., Ltd.20230—
+3K210826Healing Abutment, Cover ScrewMegagen Implant Co., Ltd.20224—
+3K201323INNO SLA Submerged Implant SystemCowellmedi Co., Ltd.20222—
+3K190637Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd.20200—
+3K192263UCLA CCM AbutmentDio Corporation20204—
+3K182194UV Active Implant SystemDio Corporation20181—
+3K173975UF (II) Wide FixtureDio Corporation20180—
+3K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+3K170608UF (II) Implant SystemDio Corporation20184—
+3K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+3K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+4K260006INOSS SystemInosys, Inc.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+4K232546Meta G UCLA AbutmentCowellmedi Co., Ltd.20230—
+4K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+4K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+4K222946Oneday Mini Implant SystemOneday Biotech Co., Ltd.20230—
+4K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+4K230203Dentis I-FIX AbutmentDentis Co., Ltd.20230—
+4K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+4K153521IH Implant SystemSewonmedix, Inc.201610—
+4K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+5K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+5K222707IH Implant SystemSewonmedix, Inc.20231—
+5K222636ET Abutment SystemHiossen, Inc.20230—
+5K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+5K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+5K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+5K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+6K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+6K240977DenQ Sub SLA Implant SystemDenq20240—
+6K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+6K222976MU SystemDentis Co., Ltd.20230—
+6K220517IBS SystemInnobiosurg Co., Ltd.20220—
+6K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+6K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+6K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—