Dio Corporation

FDA Regulatory Profile

Dio Corporation has 0 FDA recalls, 1 inspection, 14 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 11, 2010 · VAI
Latest 510(k)
Aug 18, 2023

Updated: recalls Oct 23, 2026 · inspections Oct 23, 2026 · compliance actions Oct 23, 2026.

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Summary

Recalls
0
510(k) Clearances
14
Inspections
1
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 11, 2010Haeundae, Korea (The Republic Of)DevicesVoluntary Action Indicated (VAI)3007126709

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K220253Eco Abutment, Multiunit AbutmentAug 18, 2023
K210828DIOnavi-Denture02Mar 23, 2021
K193623DIOnavi-DentureOct 22, 2020
K193404UF(II) Bar holder abutmentMay 18, 2020
K192263UCLA CCM AbutmentFeb 21, 2020
K190048UF(II) Anatomic abutmentSep 30, 2019
K181037DIO CAD/CAM AbutmentDec 21, 2018
K182194UV Active Implant SystemDec 14, 2018
K173975UF(II) Wide FixtureJun 1, 2018
K170608UF(II) Implant SystemMar 30, 2018
K161987UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - SuprastructureFeb 21, 2017
K122519DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEMMay 21, 2013
K112746DIOSLIMON IMPLANT SYSTEMOct 21, 2011
K100100DIO STEADY EXTERNAL IMPLANT SYSTEMNov 10, 2010