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
DIO STEADY External Implant System	ESF 4508R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45205H	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 4008SF	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75404N(II)	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 12 A03(a,b)	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSHA 4024	FDA UDI	Class II	Unknown
Fixture Mount	EMN 3508	FDA UDI	Class I	Active
Multi Angled Abutment	MAA 484520H	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	IPN 5008N	FDA UDI	Class I	Active
DIO Steady External Implant System	PESF 4016R	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	MSD 2514D	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DCN 5555H	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 4864T	FDA UDI	Class II	Unknown
UF(II) Eco Transfer Impression Coping	USTI 4510H	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	ABN 40503	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAN 50225	FDA UDI	Class II	Active
UF(II) Eco H-Scan Body	USNHCD 4205H	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSBA 3530	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 45404N(II)	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75105N(II)	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 45355	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	API 48514	FDA UDI	Class II	Unknown
UF(II) Eco Cemented Post	USP 6507N	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DMR 3540H	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAC 5504	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 40507H	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 455025AH	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	IPI 48610N	FDA UDI	Class II	Active
DIOnavi. Guide	GUIDE02 11(a,b)	FDA UDI	Class I	Active
DIOnavi. Tissue Punch	GTP 3430	FDA UDI	Class I	Active
UF Implant System	UF 4511S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	APT 50613	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 5516SF	FDA UDI	Class II	Active
DIO Implant System	IFI 4010PM	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DAUN 3570N	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 3810	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 75504H(II)	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DUR 4570H	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 04 A05(a,b)	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 65207N(II)	FDA UDI	Class II	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4518S	FDA UDI	Class II	Unknown
SM Implant System	SFR 5008	FDA UDI	Class II	Unknown
DIO Bone Expander Kit	BEP 01	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4015S	FDA UDI	Class II	Active
DIO Drill Stopper	ST 5504	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 06 A01(a,b)	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 40107N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPI 48002Y	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 5846	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSTA 4010H	FDA UDI	Class II	Unknown

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