510(k) Report

Devices descending from K060501

26 later devices reach Implantium II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132242Inno Sla Submerged Implant SystemCowellmedi Co., Ltd.20133—
+1K122519Dio UF Hsa Internal Sub-Merged Implant SystemDio Corporation201312—
+1K102308Simpleline II Model SOFX483408R, SOFX483410R Total 44 ModelsDentium Co., Ltd.20100—
+1K081748Oneplant Dental Implant SystemWarantec Co., Ltd.20099—
+2K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+2K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+2K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+2K201323INNO SLA Submerged Implant SystemCowellmedi Co., Ltd.20222—
+2K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+2K182194UV Active Implant SystemDio Corporation20181—
+2K173975UF (II) Wide FixtureDio Corporation20180—
+2K172100URIS OMNI SystemTruabutment, Inc.20187—
+2K170608UF (II) Implant SystemDio Corporation20184—
+2K103280Bhdental Implant SystemBhdental, Ltd.20110—
+3K260006INOSS SystemInosys, Inc.20260—
+3K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+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—
+3K222946Oneday Mini Implant SystemOneday Biotech Co., Ltd.20230—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—