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	SSCA 65204N(II)	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSBA 3560	FDA UDI	Class II	Active
DIO H-Scan Body	ITHSB 662	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45507H(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 40519N	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 5844N(II)	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SASA 3906	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFP 25410	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ESF 4008R	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65104H(II)	FDA UDI	Class II	Unknown
DIO Abutment Removing Driver	HARD 20325A	FDA UDI	Class I	Active
UF(II) Eco Base Abutment	USBA 5501H	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 65205	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PETF 4011R	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ESF 6013R	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFB 20208	FDA UDI	Class II	Unknown
DIO Biotite-H Implant System	SFR 4508H	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DLN 1555N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 75207	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF 5016S	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF 3810S	FDA UDI	Class II	Unknown
DIO Biotite-H Implant System	SFN 4108H	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55304N(II)	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DAUN 5555N	FDA UDI	Class II	Unknown
DIO Implant System	IFI 4810PM	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DLN 3555H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	HMI 48555EX	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DAUN 3555N	FDA UDI	Class II	Unknown
UF(II) Eco Cemented Post	USP 5504H	FDA UDI	Class II	Active
UF Implant System	SWF 6014S	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 455015BH	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 10	FDA UDI	Class I	Active
DIO Screw Driver	HD 1230A	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DACN 2570H	FDA UDI	Class II	Unknown
DIO Implant Systems	IFI 3510PM	FDA UDI	Class II	Unknown
DIOnavi. Abutment Jig	AJ3D 01	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 4844(II)	FDA UDI	Class II	Unknown
UF(II) Narrow Scan Adapter Screw	UNSCAN 1410H	FDA UDI	Class I	Active
DIO Steady External Implant System	ETF 6010R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40604N	FDA UDI	Class II	Unknown
DIO Implant System	IFI 3514PM	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75305N(II)	FDA UDI	Class II	Unknown
UF(II) Eco Cemented Post	USP 4804H	FDA UDI	Class II	Active
UV Active Implant System	UF(II) 3813UV3	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DUN 1555N	FDA UDI	Class II	Unknown
UF(II) Narrow Pre-Milled Bar	CBUN 02N	FDA UDI	Class I	Active
UF(II) Fixture	UF(II) 4007SF	FDA UDI	Class II	Active
Dio Implant Systems	AMI 35007	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 4313M	FDA UDI	Class I	Active
Fixture Mount	EMN 3508T	FDA UDI	Class I	Active

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