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
DIOnavi. Straight Drill	USD 2707	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	ABI 48354	FDA UDI	Class II	Unknown
Protem Fixture Driver Assy	MGR 3510A	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DPR 4555H	FDA UDI	Class II	Unknown
UF Implant System	UF 4511S<VerA>	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DAUR 4555H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	HMI 48554EX	FDA UDI	Class II	Active
Mill Abutment	UNSMA 4030H	FDA UDI	Class II	Active
DIO Straight Drill	DSU 3015M	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AMN 50631N	FDA UDI	Class II	Unknown
DIO Implant System	IFI 6510PM	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DMR 4555H	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3008SF	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SASC 4804	FDA UDI	Class II	Unknown
DIOnavi. Guide Drill	UGD 2005W	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 45204	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DACN 5555N	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DCN 4570N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 454025BH	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 6814N(II)	FDA UDI	Class II	Unknown
UF(II) Narrow Protect Cap	DACLN 55	FDA UDI	Class I	Active
UF(II) Wide	UF(II) 7010S	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SIT 5202T	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 45155	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 5010B	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DACN 1570N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	RT 0502	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 65504	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45605H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	RMT 50512	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAA 58115A	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 5834N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPT 5008N	FDA UDI	Class I	Active
UF(II) UCLA Plastic Abutment	SSPA 5512N[H]	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSMUA 483020N	FDA UDI	Class II	Active
DIOnavi. Guide (Anchor system)	GUIDE02 05 A01(a,b)	FDA UDI	Class I	Active
DIO Steady External Implant System	PESF 4010R	FDA UDI	Class II	Unknown
Angled Abutment	AAN 40415[H]	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 45705H	FDA UDI	Class II	Unknown
DIO Master Kit	UF(M) 05<VerP>	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DUN 3570H	FDA UDI	Class II	Unknown
UF(II) Eco Pickup Impression Coping	USPI 5506H	FDA UDI	Class I	Active
Protem Fixture Driver	MGC 3510	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	PCN 40310	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 4311M	FDA UDI	Class I	Active
UCLA Plastic Abutment	APN 50613N[H]	FDA UDI	Class II	Active
Dio Protem Implant System	MFP 20214	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 55205H(II)	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 45505	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 09 A04	FDA UDI	Class I	Active

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