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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 98 of 111| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| UF(II) Implant System | SSCA 65305H(II) | FDA UDI | Class II | Unknown |
| DIO Straight Drill | DSU 2015M<VerA> | FDA UDI | Class I | Active |
| DIO Round Drill | GSRD 3218 | FDA UDI | Class I | Active |
| DIO Fixture Removing Driver | FRD 11L<VerA> | FDA UDI | Class I | Active |
| FTN Tapered Drill | DTH 5013S | FDA UDI | Class I | Active |
| Dio Uf Hsa Internal Sub-Merged Implant System | IPI 60710 | FDA UDI | Class II | Unknown |
| UF(II) Narrow Implant System | UNSCA 45604H | FDA UDI | Class II | Active |
| UF(II) Implant System | UNSSA 40204 | FDA UDI | Class II | Unknown |
| DIO STEADY External Implant System | ESF 6013R | FDA UDI | Class II | Unknown |
| Dio Sm-Extra Wide(rbm) Implant Systems | SAC 4864T(II) | FDA UDI | Class II | Unknown |
| UF Implant System | UF(II) 5508S | FDA UDI | Class II | Unknown |
| UF Implant System | PUF(II) 5007S | FDA UDI | Class II | Unknown |
| DIO UF HSA Internal Sub-Merged Implant System | UF(II) 5510S | FDA UDI | Class II | Unknown |
| Dio Implant Systems | AEI 35007 | FDA UDI | Class II | Unknown |
| Dio Sm-Extra Wide(rbm) Implant Systems | SAC 5845T(II) | FDA UDI | Class II | Unknown |
| Dio Sm-Extra Wide(rbm) Implant Systems | SAS 5867(II) | FDA UDI | Class II | Unknown |
| Dio Uf Hsa Internal Sub-Merged Implant System | SSHA 7524 | FDA UDI | Class II | Active |
| UF(II) Implant System | SSCA 65505H(II) | FDA UDI | Class II | Active |
| UF(II) Implant System | SSSA 75105 | FDA UDI | Class II | Unknown |
| Dio Sm-Extra Wide(rbm) Implant Systems | SAS 6824(II) | FDA UDI | Class II | Unknown |
| Sm Internal/External Implant Systems | TCN 40511N | FDA UDI | Class II | Active |
| Dio Uf Hsa Internal Sub-Merged Implant System | SSBA 3530 | FDA UDI | Class II | Active |
| Dio Uf Hsa Internal Sub-Merged Implant System | SSAA 4507 | FDA UDI | Class I | Active |
| UF(II) Digital Lab Analog | MDAR 4814 | FDA UDI | Class I | Active |
| Sm Internal/External Implant Systems | PCN 40312 | FDA UDI | Class II | Unknown |
| Sm Internal/External Implant Systems | AGT 50614N | FDA UDI | Class II | Unknown |
| Dio Sm-Extra Wide(rbm) Implant Systems | SAS 7837(II) | FDA UDI | Class II | Unknown |
| Dio Uf Hsa Internal Sub-Merged Implant System | SSMA 5525H | FDA UDI | Class II | Unknown |
| UF(II) Implant System | UF(II) 4015SF | FDA UDI | Class II | Unknown |
| DIO Straight Drill | DSU 3210M | FDA UDI | Class I | Active |
| UF(II) Anatomic abutment | DALR 4555N | FDA UDI | Class II | Unknown |
| DIO STEADY External Implant System | ESF 3716R | FDA UDI | Class II | Unknown |
| Dio Uf Hsa Internal Sub-Merged Implant System | SSTI 4015H | FDA UDI | Class II | Active |
| DIO Drill Stopper | ST 4000F | FDA UDI | Class I | Active |
| Dio Protem Implant System | MFB 25210 | FDA UDI | Class II | Active |
| DIOnavi. Straight Drill | USD 3805 | FDA UDI | Class I | Active |
| DIO Steady External Implant System | ESF 6016R | FDA UDI | Class II | Unknown |
| Sm Internal/External Implant Systems | ITN 40512H | FDA UDI | Class I | Active |
| Dio Sm-Extra Wide(rbm) Implant Systems | SAC 7834T(II) | FDA UDI | Class II | Unknown |
| DIO UF HSA Internal Sub-Merged Implant System | UF 3813S | FDA UDI | Class II | Unknown |
| UF(II) Implant System | SSCA 65405N(II) | FDA UDI | Class II | Unknown |
| UF(II) Implant System | SSCA 55507N(II) | FDA UDI | Class II | Active |
| UF(II) Pick-up Impression Coping | SSPI 4519N | FDA UDI | Class I | Active |
| UF(II) Anatomic abutment | DCR 1555H | FDA UDI | Class II | Unknown |
| UF(II) Anatomic abutment | DLN 4555N | FDA UDI | Class II | Unknown |
| UF(II) Implant System | UF(II) 5010SF | FDA UDI | Class II | Unknown |
| Sm Internal/External Implant Systems | ACN 50623 | FDA UDI | Class II | Unknown |
| Sm Internal/External Implant Systems | APN 35413 | FDA UDI | Class II | Unknown |
| Sm Internal/External Implant Systems | ITT 50612S | FDA UDI | Class I | Active |
| DIO Steady External Implant System | PETF 5013R | FDA UDI | Class II | Unknown |
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