510(k) Report

Devices descending from K122519

12 later devices reach Dio UF Hsa Internal Sub-Merged Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+1K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+1K182194UV Active Implant SystemDio Corporation20181—
+1K173975UF (II) Wide FixtureDio Corporation20180—
+1K170608UF (II) Implant SystemDio Corporation20184—
+2K260006INOSS SystemInosys, Inc.20260—
+2K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+2K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+2K222946Oneday Mini Implant SystemOneday Biotech Co., Ltd.20230—
+2K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+3K192839DSP Implant SystemD.S.P Industrial Eireli20210—