# Dio Corporation

- Location (FDA's records): Busan, KR
- FDA decisions: 14 (2010–2023): 14 510(k) clearances
- Product codes: DZE (7), NHA (5), EBI (2)
- 510(k) review time since 2016: median 217 days, against 200 for FDA's reviews in the same codes and years (4 of 11 faster)
- Predicates its devices cite: 15 (4 its own); citations of its devices by later devices: 20 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dio Department Dsi, Inc.: 2 (https://510kreport.com/company/dio-department-dsi)
- Dentca, Inc.: 1 (https://510kreport.com/company/dentca)
- Nobel Biocare AB: 1 (https://510kreport.com/company/nobel-biocare)
- Osstem Implant Co., Ltd.: 1 (https://510kreport.com/company/osstem-implant)
- Institut Straumann AG: 1 (https://510kreport.com/company/institut-straumann)
- Dentium Co., Ltd.: 1 (https://510kreport.com/company/dentium)
- Medentika GmbH: 1 (https://510kreport.com/company/medentika)
- Zimmer Dental, Inc.: 1 (https://510kreport.com/company/zimmer-dental)

## Firms that cite its devices most
- Dentis Co., Ltd.: 3 (https://510kreport.com/company/dentis)
- Izenimplant Co., Ltd.: 2 (https://510kreport.com/company/izenimplant)
- DIMPLO, Ltd.: 2 (https://510kreport.com/company/dimplo)
- Cowellmedi Co., Ltd.: 2 (https://510kreport.com/company/cowellmedi)
- Oneday Biotech Co., Ltd.: 2 (https://510kreport.com/company/oneday-biotech)
- Innobiosurg Co., Ltd.: 1 (https://510kreport.com/company/innobiosurg)
- Implacil DE Bortoli Material Odontologico Ltda: 1 (https://510kreport.com/company/implacil-de-bortoli-material-odontologico)
- Idis Co., Ltd.: 1 (https://510kreport.com/company/idis)

## Its most-cited devices
- K122519: Dio UF Hsa Internal Sub-Merged Implant System (2013), cited by 5
- K181037: DIO CAD/CAM Abutment (2018), cited by 5
- K161987: UF (II) Narrow Implant System - Fixture, UF (II) Narrow Implant System - Suprastructure (2017), cited by 3
- K170608: UF (II) Implant System (2018), cited by 2
- K192263: UCLA CCM Abutment (2020), cited by 2
- K193623: DIOnavi-Denture (2020), cited by 1

## Recent decisions
- K220253: Eco Abutment, Multiunit Abutment (Aug 18, 2023)
- K210828: DIOnavi-Denture02 (Mar 23, 2021)
- K193623: DIOnavi-Denture (Oct 22, 2020)
- K193404: UF (II) Bar holder abutment (May 18, 2020)
- K192263: UCLA CCM Abutment (Feb 21, 2020)
- K190048: UF (II) Anatomic abutment (Sep 30, 2019)
- K181037: DIO CAD/CAM Abutment (Dec 21, 2018)
- K182194: UV Active Implant System (Dec 14, 2018)

Source page: https://510kreport.com/company/dio