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 Drill Stopper	ST 2010F	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSAA 404015AH	FDA UDI	Class II	Active
FTN Scan Adapter	SCAN 04-15[H]	FDA UDI	Class I	Active
UF(II) Internal Impression Cap	IPI 60001	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45207H(II)	FDA UDI	Class II	Active
FTN Tapered Drill	DTH 5008SM	FDA UDI	Class I	Active
Dio Protem Implant System	MFP 25212	FDA UDI	Class II	Active
Dio Protem Implant Systems	MBC 3803	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 45504H(II)	FDA UDI	Class II	Unknown
DIO Implant Systems	IFI 6514PM	FDA UDI	Class II	Unknown
FTN Fixture Mount Screw	MAN 5007-2	FDA UDI	Class I	Active
DIOnavi. Abutment Jig	AJ3D 05H	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DCR 4555N	FDA UDI	Class II	Unknown
DIO Implant System	PSI 4812	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 5826N	FDA UDI	Class II	Unknown
UF(II) Bar holder abutment	MBHCA 4506N	FDA UDI	Class II	Active
DIO Steady External Implant System	PETF 4515R	FDA UDI	Class II	Unknown
DIOnavi. Implant Connector	GNIC 5309	FDA UDI	Class I	Active
DIOnavi. Tap Drill	GTD 6515	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 5845(II)	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 45254	FDA UDI	Class II	Unknown
DIO Square Hex Screw Driver	SHD 1215	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 551515N	FDA UDI	Class II	Active
DIO Solid Abutment Driver	HDS 4512A	FDA UDI	Class I	Active
DIOnavi. Tissue Punch	GTP 5125	FDA UDI	Class I	Active
FTN Tapered Drill	DTH 5013SD	FDA UDI	Class I	Active
UF(II) Tap Drill	UT(II) 6506	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 45307N	FDA UDI	Class II	Unknown
UF Implant System	UF(II) 5011S	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40304H	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ETF 4515R	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 3916N	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ESF 4510R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45704N	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 5013S	FDA UDI	Class II	Unknown
DIO Screw Driver	MD 0922	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 4844T(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	HMI 65705	FDA UDI	Class II	Active
DIOnavi. Connector Extension	CE 6512A	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 75155	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 3924	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PSWF 6506S	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 3966T	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DLR 1570H	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SASA 5808	FDA UDI	Class II	Unknown
DIOnavi. Profile Drill	GPD 3305M	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	ACN 50634	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DALN 3555H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	TMN 40512	FDA UDI	Class II	Unknown
DIOnavi. Guide Sleeve	GSC 53BL	FDA UDI	Class I	Active

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