Question 1

What types of medical devices does DIO Corporation manufacture?

Accepted Answer

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.

Question 2

Where is DIO Corporation based, and what markets do they serve?

Accepted Answer

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.

Question 3

Which regulatory registries list DIO Corporation’s devices?

Accepted Answer

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.

Question 4

How are DIO Corporation’s devices classified under EU regulations?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
UF(II) Fixture	UF(II) 7005S	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	ACN 50623	FDA UDI	Class II	Active
UV Active Implant System	UF(II) 3810UV3	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 4513SF	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 45304N	FDA UDI	Class II	Unknown
UCLA Plastic Abutment	APN 50613[H]	FDA UDI	Class II	Active
UF(II) Trephine Drill	TRD 4032	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAF 3812	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75404N(II)	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 4507SF	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 5535	FDA UDI	Class II	Unknown
DIOnavi. Connector Extension	CE 6508A	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 4825	FDA UDI	Class II	Unknown
Dio Implant Systems	RMI 65004	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 45555	FDA UDI	Class II	Unknown
FTN Fixture Mount	EMN 3508[H]	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 4508SF	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAC 5504	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 50639	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DPR 1570H	FDA UDI	Class II	Unknown
UF(II) Scan Adapter	SCAN 6102H	FDA UDI	Class I	Active
DIO STEADY External Implant System	ETF 4513R	FDA UDI	Class II	Unknown
UF(II) Wide	UF(II) 7007SF	FDA UDI	Class II	Active
UF(II) Wide	UF(II) 6008SF	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 40305H	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSKA 4801	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 4835N(II)	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SIP 3907N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 75305	FDA UDI	Class II	Unknown
UF(II) Wide	UF(II) 7010SF	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 4814	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	TCN 40512N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 4238	FDA UDI	Class II	Unknown
DIO New Dr. SOS+ Kit	DRS 05	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 65404H(II)	FDA UDI	Class II	Active
UF(II) Implant System	UNSSA 40205	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 454015AH	FDA UDI	Class II	Unknown
UF(II) Eco Cemented Post	USP 4504N	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 40505N	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 06 A01	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 5508S	FDA UDI	Class II	Unknown
DIOnavi-Denture02	3DDEN02-1000P1	FDA UDI	Class II	Active
Secure Implant System	MFB 30216A	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 5013S	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 4807	FDA UDI	Class I	Active
DIO Steady External Implant System	ETF 3308R	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ETF 3315R	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DLN 1555H	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	SWF 6510S	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55405H(II)	FDA UDI	Class II	Unknown

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