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 UF HSA Internal Sub-Merged Implant System	UF(II) 5518S	FDA UDI	Class II	Active
DIO Screw Driver	HD 1705A	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AMI 48357	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	ICC 65309N	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 05 A05	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AMI 48007N	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 55104N(II)	FDA UDI	Class II	Unknown
DIO Implant Systems	PSI 4012P	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	PMN 35310	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAP 7510S	FDA UDI	Class I	Active
UF(II) Eco Pickup Impression Coping	USPI 6506H	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 05 A03	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UF(II)N 3010S	FDA UDI	Class II	Active
DIOnavi Guide	GUIDE 02 A03(a,b)	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	BC 5004	FDA UDI	Class II	Active
UF(II) Narrow Guide pin	MGP 1620	FDA UDI	Class I	Active
DIO Implant Systems	IFI 4010M	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SIP 4810N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 4848	FDA UDI	Class II	Unknown
DIO Guide Sinus Approach Stopper	LST 30BL	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45107H(II)	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DLR 1555H	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PSWF 7006S	FDA UDI	Class II	Unknown
UF(II) Wide	UF(II) 7013S	FDA UDI	Class II	Active
DIO Steady External Implant System	ESF 5008R	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSTA 4530N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 45207N(II)	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 5011B	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 4537	FDA UDI	Class II	Unknown
DIO Implant Systems	FTN 4015B	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 35431	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 4838	FDA UDI	Class II	Unknown
Dio Implant Systems	ITI 35010	FDA UDI	Class II	Unknown
UF(II) Eco Angled Post	USAP 450806AH	FDA UDI	Class II	Active
DIOnavi. Guide (Anchor system)	GUIDE02 04 A01(a,b)	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	RCI 48014	FDA UDI	Class II	Unknown
DIO Screw Driver	MD 1234L	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 45505	FDA UDI	Class II	Active
UF(II) Fixture	UF(II) 5005S	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSMUA 484020N	FDA UDI	Class II	Unknown
DIO Implant Systems	FTT 5011B	FDA UDI	Class II	Unknown
UF(II) Narrow Solid Abutment Analog	UNSSAA 4007	FDA UDI	Class I	Active
FTN Counter Sinker	NCS 4108	FDA UDI	Class I	Active
DIOnavi. Implant Connector	GWIC 6808ST<VERC>	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	SHT 2011S	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55505H(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 40517	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 4310M	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4016S	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 40405H	FDA UDI	Class II	Active

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