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Sign in to claim this brandDIO Corporation
South Korea·KR-MF-000008515
Last updated September 17, 2026
What DIO Corporation makes
DIO Corporation manufactures dental implant components, including permanent and temporary preformed suprastructures, reusable and single-use dental fixtures, and guided surgery reference plates. Their portfolio also covers endosteal dental implants, dental prosthesis/implant abutment screws, reusable surgical screwdrivers, and depth limiters for dental instruments. Example products include implant systems, abutment caps, and guided surgery jigs designed for precision in dental procedures.
The company’s devices are classified under EU regulations as Class I, Class II, Class IIa, and Class IIb, with listings in the EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The manufacturer operates from South Korea, adhering to regulatory requirements for dental implants and surgical instruments in both European and U.S. markets.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does DIO Corporation manufacture?
DIO Corporation specializes in dental implant components and related surgical tools. Their portfolio includes permanent and temporary preformed dental implant suprastructures, reusable and single-use dental fixtures like drill bits and abutment screws, endosteal dental implants (two-piece systems), guided surgery reference plates, and reusable surgical screwdrivers. These devices are designed to support dental restoration procedures, ensuring precision and compatibility with implant systems.
Where is DIO Corporation based, and what markets do they serve?
DIO Corporation is headquartered in South Korea. Their devices are intended for use in both European and U.S. markets, as evidenced by their listings in the EUDAMED database (for EU regulatory compliance) and the FDA’s Unique Device Identifier (UDI) system (for U.S. traceability). This indicates their products meet the regulatory requirements of these regions for dental implants and surgical instruments.
Which regulatory registries list DIO Corporation’s devices?
DIO Corporation’s devices are listed in two key regulatory databases: EUDAMED, the European Union’s medical device registry, and the FDA’s UDI system, which tracks medical devices in the United States. These listings help ensure transparency and traceability of their products in both markets, where their devices are authorised for use.
How are DIO Corporation’s devices classified under EU regulations?
Under EU medical device regulations, DIO Corporation’s products fall into Class I, Class II, Class IIa, and Class IIb classifications. The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety—for example, implant systems and guided surgery tools are typically higher-risk (Class II or IIb) due to their invasive nature and critical role in dental procedures, while reusable fixtures like drill bits may fall into lower-risk categories like Class I or IIa.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- South Korea
- Address
- 66, Centumseo-ro, Busan, South Korea
- Website
- www.dioimplant.com
- —
- —
- [email protected]
- Phone
- +82-745-7777
- PRRC Contact
- Jong-hyuck Seo
- EUDAMED SRN
- KR-MF-000008515
- FDA FEI Number
- 3007126709
- DUNS Number
- 631085206
Catalogue (5538)
Page 12 of 111| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| UFIII Fixture | UFIII 4010S | FDA UDI | Class II | Active |
| Sm Internal/External Implant Systems | AAN 40425 | FDA UDI | Class II | Unknown |
| UF(II) Narrow Implant System | UNSCA 40507N | FDA UDI | Class II | Unknown |
| DIO Straight Drill | DSU 3813D | FDA UDI | Class I | Active |
| Dio Sm-Extra Wide(rbm) Implant Systems | SAS 7844(II) | FDA UDI | Class II | Unknown |
| Dio Sm-Extra Wide(rbm) Implant Systems | SAC 5814T(II) | FDA UDI | Class II | Unknown |
| UF(II) Narrow Fixture Driver Contra Angle | UNFDC 3018 | FDA UDI | Class I | Active |
| Sm Internal/External Implant Systems | AGN 50614 | FDA UDI | Class II | Unknown |
| Dio Biotite-H Implant Systems | SAC 4824T | FDA UDI | Class II | Unknown |
| UF(II) Internal Fixture Driver | OFDW 4806A | FDA UDI | Class I | Active |
| DIO UF HSA Internal Sub-Merged Implant System | UF 3810S<VerA> | FDA UDI | Class II | Unknown |
| UF(II) Narrow Implant System | UF(II)N 3308SF | FDA UDI | Class II | Active |
| DIO Implant Systems | IFI 4014M | FDA UDI | Class II | Unknown |
| Sm Internal/External Implant Systems | AMN 35442N | FDA UDI | Class II | Unknown |
| Dio Sm-Extra Wide(rbm) Implant Systems | SAC 4865N(II) | FDA UDI | Class II | Unknown |
| Sm Internal/External Implant Systems | AHN 40506 | FDA UDI | Class II | Unknown |
| DIO STEADY External Implant System | ETF 4516R | FDA UDI | Class II | Unknown |
| DIOnavi. Straight Drill | MSD 2018D<VerA> | FDA UDI | Class I | Active |
| DIO UF HSA Internal Sub-Merged Implant System | UF(II) 4015S | FDA UDI | Class II | Unknown |
| Sm Internal/External Implant Systems | ITN 50612 | FDA UDI | Class II | Unknown |
| DIO UF HSA Internal Sub-Merged Implant System | UF(II) 4016S | FDA UDI | Class II | Unknown |
| Sm Internal/External Implant Systems | AMN 35419 | FDA UDI | Class II | Unknown |
| DIO Straight Drill | DSU 2015D | FDA UDI | Class I | Active |
| DIOnavi. Straight Drill | USD 2711 | FDA UDI | Class I | Active |
| UF(II) Implant System | SSCA 65207H(II) | FDA UDI | Class II | Active |
| Sm Internal/External Implant Systems | SHN 2011 | FDA UDI | Class II | Active |
| Dio Protem Implant System | MFP 25408 | FDA UDI | Class II | Active |
| UF(II) Narrow Implant System | UNSCA 40505H | FDA UDI | Class II | Unknown |
| FTN Tapered Drill | DTH 3311SM | FDA UDI | Class I | Active |
| Sm Internal/External Implant Systems | TMN 35412 | FDA UDI | Class II | Unknown |
| Dio Uf Hsa Internal Sub-Merged Implant System | SSCS 3420 | FDA UDI | Class II | Unknown |
| Dio Uf Hsa Internal Sub-Merged Implant System | SSSA 45554 | FDA UDI | Class II | Unknown |
| Dio Uf Hsa Internal Sub-Merged Implant System | SSHA 6535 | FDA UDI | Class II | Unknown |
| UF Implant System | UF(II) 5510S | FDA UDI | Class II | Unknown |
| DIO Implant System | PSI 3514P | FDA UDI | Class II | Unknown |
| UF(II) Narrow Implant System | UNSCA 40407H | FDA UDI | Class II | Active |
| Sm Internal/External Implant Systems | APN 50613N | FDA UDI | Class II | Unknown |
| DIO Membrane Lifter Tube | MLT 40300 | FDA UDI | Class I | Active |
| DIOnavi. Profile Drill | GPD 4505 | FDA UDI | Class I | Active |
| UF(II) Implant System | SSCA 65104N(II) | FDA UDI | Class II | Active |
| UF(II) Anatomic abutment | DCN 1555H | FDA UDI | Class II | Unknown |
| Extension Cemented Abutment | AEI 48007N[H] | FDA UDI | Class II | Active |
| Dio Uf Hsa Internal Sub-Merged Implant System | SSOA 4855 | FDA UDI | Class II | Active |
| UF(II) Implant System | SSCA 75205H(II) | FDA UDI | Class II | Active |
| UF(II) Anatomic abutment | DLR 1570N | FDA UDI | Class II | Unknown |
| UF(II) Anatomic abutment | DCN 3555H | FDA UDI | Class II | Unknown |
| Dio Sm-Extra Wide(rbm) Implant Systems | SAC 7844N(II) | FDA UDI | Class II | Unknown |
| Dio Uf Hsa Internal Sub-Merged Implant System | SSAA 453015N | FDA UDI | Class II | Active |
| FTN Fixture Mount | EMW 5008[H] | FDA UDI | Class I | Active |
| DIOnavi. Straight Drill | USD 2710 | FDA UDI | Class I | Active |
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