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-Denture02	3DDEN02-500P1	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55504H(II)	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 45205N(II)	FDA UDI	Class II	Unknown
Periosteal Elevator	MIT 01	FDA UDI	Class I	Active
Cylinder Screw	MSC 1604	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	IPN 40512N	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 35403	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSHA 4558	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 3018D	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	SHN 2010	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	IPI 48002B	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 4313M	FDA UDI	Class I	Active
UF(II) Implant System	UNSSA 45105	FDA UDI	Class II	Active
FTN Fixture Driver	HGC 4024	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 40504N	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF 4507S	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 453025N	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 3818	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPI 48004	FDA UDI	Class II	Active
UF(II) Internal Pick-up Impression Coping	IPI 60012N	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DALN 1555H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	TMN 40512N	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AGN 50604N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAB 4502	FDA UDI	Class II	Unknown
DIO Screw Guide Tap	SGT 1618A	FDA UDI	Class I	Active
UF Implant System	UF 3808S<VerA>	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SASP 3910S	FDA UDI	Class II	Unknown
DIOnavi. Guide sleeve	GS 68GN_50	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AMN 50628	FDA UDI	Class II	Unknown
UF Implant System	UF 5013S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AEI 48027N	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 6865N(II)	FDA UDI	Class II	Unknown
DIOnavi. Initial Drill	ISD 2011M<VerA>	FDA UDI	Class I	Active
FTN Tapered Drill	DTH 4015SD	FDA UDI	Class I	Active
Dio Protem Implant System	MFB 25208	FDA UDI	Class II	Active
Dio Sm Implant System	SAHN 4113	FDA UDI	Class II	Unknown
SM Implant System	SFN 3810	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DUR 4570N	FDA UDI	Class II	Unknown
DIOnavi. Guide sleeve	GS 53RD	FDA UDI	Class I	Active
UF(II) Bar holder abutment	UNMBHA 4506N	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSMUA 484020H	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSHA 4058	FDA UDI	Class II	Active
DIOnavi. Straight Drill	MSD 2014D	FDA UDI	Class I	Active
Multi Angled Abutment	MAA 482520H	FDA UDI	Class II	Active
DIOnavi. Guide (Anchor system)	GUIDE02 02 A02(a,b)	FDA UDI	Class I	Active
Extension Cemented Abutment	AEI 48017N[H]	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAB 3902	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 2707M	FDA UDI	Class I	Active
DIOnavi. Bone Flattening Drill	UBFD 5127	FDA UDI	Class I	Active
Bone Condenser	MIT 08	FDA UDI	Class I	Active

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