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) Implant System	SSSA 65105	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PSWF 7008S	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 4510SF	FDA UDI	Class II	Active
Secure Implant System	MFB 30212A	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DCN 5555N	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DUN 4570N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 7505	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 6504	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	RMI 48005EX	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 7824N(II)	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAC 4507	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 5508SF	FDA UDI	Class II	Active
DIO Drill Stopper	ST 4007	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AMI 48027N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	IOTI 60010	FDA UDI	Class II	Unknown
DIOnavi. Profile Drill	GPD 4005	FDA UDI	Class I	Active
DIO Parallel Pin	PP 1523	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DACN 3555N	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3010S	FDA UDI	Class II	Unknown
UFIII Fixture	UFIII 5008S	FDA UDI	Class II	Active
Secure Implant System(2.5/3.0mm)	MHC 5006	FDA UDI	Class II	Active
UF(II) Eco Transfer Impression Coping	USNTI 4210H	FDA UDI	Class I	Active
DIOnavi. Scan Retractor Upper jaw Set	SCANR 01S	FDA UDI	Class I	Active
DIO Steady External Implant System	ETF 6008R	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	SWF 6014S	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 4824	FDA UDI	Class II	Unknown
DIO Megagen Scan Adapter	SCAN 17[H]	FDA UDI	Class I	Active
DIO Steady External Implant System	ETF 4513R	FDA UDI	Class II	Unknown
UF(II) Eco Angled Post	USAP 480806AH	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTA 4510H	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	APT 50613N	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DALN 3570H	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55105H(II)	FDA UDI	Class II	Active
DIO Implant Systems	FTN 3315B	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSMA 4015H	FDA UDI	Class II	Unknown
UFIII Fixture	UFIII 5011UV3	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 6515N	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 75505	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAC 3946N	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 4015S	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 6817(II)	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 3215M	FDA UDI	Class I	Active
DIO Zimmer Scan Adapter	SCAN 08[T]	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSTA 4030N	FDA UDI	Class II	Active
Dio Protem Implant System	MFP 25208	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 3813S	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 6545	FDA UDI	Class II	Unknown
Bone Expander	BEP 1744	FDA UDI	Class I	Active
Secure Implant System	MFB 30416A	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45705N	FDA UDI	Class II	Active

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