Is this your brand? Sign in to claim ownership.
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 111 of 111| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Angled Abutment | AAT 50425[H] | FDA UDI | Class II | Active |
| UF(II) Internal Fixture Analog | RMI 60012Y | FDA UDI | Class I | Active |
| FTN H-Scan Body | ERHSB 541H | FDA UDI | Class I | Active |
| UF(II) Narrow Protect Cap | UNSAC 4005 | FDA UDI | Class I | Active |
| Protem Straight Drill | MSD 1518M | FDA UDI | Class I | Active |
| Fixture Mount | EMR 41210 | FDA UDI | Class I | Active |
| DIO Multi Screw Driver | MSD 1420 | FDA UDI | Class I | Active |
| DIOnavi. Straight Drill | USD 2719 | FDA UDI | Class I | Active |
| Veltz-C&B | 3DCNB-1000A3<VerA> | FDA UDI | Class I | Active |
| UFIII Fixture | UFIII 3811S | EUDAMEDFDA UDI | Class II | Active |
| UF(II) Narrow DA Protect Cap | DCCN 55 | FDA UDI | Class I | Active |
| DIOnavi. Straight Drill | USD 3217 | FDA UDI | Class I | Active |
| FTN Tapered Drill | DTH 4508SM | FDA UDI | Class I | Active |
| DIO Straight Drill | DSU 2015M | FDA UDI | Class I | Active |
| Wax Denture | WDL 02 | FDA UDI | Class I | Active |
| UF(II) Wide Surgical Kit | UF 09<VerB> | FDA UDI | Class I | Active |
| DIOnavi. Initial Drill | ISD 2016N<VerA> | FDA UDI | Class I | Active |
| FTN Scan Adapter Screw | ESSC 1608H | FDA UDI | Class I | Active |
| DIO Sinus Approach Round Drill | SRD 3613 | FDA UDI | Class I | Active |
| UF(II) Narrow Scan Adapter | SCAN 41 | FDA UDI | Class I | Active |
| DIOnavi-Denture | K193623 | FDA 510(k) | Class II | Active |
| UF(II) Implant System | K170608 | FDA 510(k) | Class II | Active |
| UV Active Implant System | K182194 | FDA 510(k) | Class II | Active |
| UCLA CCM Abutment | K192263 | FDA 510(k) | Class II | Active |
| UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure | K161987 | FDA 510(k) | Class II | Active |
| Dioslimon Implant System | K112746 | FDA 510(k) | Class II | Active |
| Dio Steady External Implant System | K100100 | FDA 510(k) | Class II | Active |
| Dio Uf Hsa Internal Sub-Merged Implant System | K122519 | FDA 510(k) | Class II | Active |
| UF(II) Bar holder abutment | K193404 | FDA 510(k) | Class II | Active |
| Eco Abutment, Multiunit Abutment | K220253 | FDA 510(k) | Class II | Active |
| UF(II) Wide Fixture | K173975 | FDA 510(k) | Class II | Active |
| DIO CAD/CAM Abutment | K181037 | FDA 510(k) | Class II | Active |
| DIOnavi-Denture02 | K210828 | FDA 510(k) | Class II | Active |
| UF(II) Anatomic abutment | K190048 | FDA 510(k) | Class II | Active |
| P010201 | Catalog_UFll_UFIII Internal Submerged System | EUDAMED | Class I | Active |
| DIO Multi Unit Abutment Holder | MAH 1425 | EUDAMEDFDA UDI | Class I | Active |
| DIOnavi. Anchor Screw | Catalog_UFll_UFIII Internal Submerged System | EUDAMEDFDA UDI | Class I | Active |
| Catalog_UFll_UFIII Internal Submerged System | Catalog_UFll_UFIII Internal Submerged System | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.