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. Anchor Screw	ASC 1520	FDA UDI	Class I	Active
DIO Implant Systems	IFI 3514PM	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	SHN 1403	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SSC 2008H	FDA UDI	Class II	Unknown
DIO Sinus Approach Stopper	ST 03BL	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 4511SF	FDA UDI	Class II	Unknown
DIO Implant Systems	IFI 3512PM	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 7513	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAA 39325	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSPI 5510N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 4868	FDA UDI	Class II	Unknown
Dio Implant Systems	AEI 35027	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 4504	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65107N(II)	FDA UDI	Class II	Active
Dio Implant Systems	AMI 35017	FDA UDI	Class II	Unknown
DIOnavi. Anchor Drill	AD 2019	FDA UDI	Class I	Active
UF(II) Wide Surgical Kit	UF 11<VerG>	FDA UDI	Class I	Active
DIO Implant System	PSI 4010	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 7524	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SSG 2020	FDA UDI	Class II	Unknown
DIO Implant System	IFI 4012PM	FDA UDI	Class II	Unknown
UF Implant System	PUF(II) 5015S	FDA UDI	Class II	Unknown
UF(II) Internal Plastic Coping	IPI 60004N	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 5013SF	FDA UDI	Class II	Unknown
Protem Fixture Driver	MGC 3520	FDA UDI	Class I	Active
DIO Implant Systems	FSN 3308B	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPI 65004	FDA UDI	Class II	Unknown
DIO Round Drill	GSRD 2817	FDA UDI	Class I	Active
UF(II) Implant System	SSCS 3410S	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 554025N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 4515N	FDA UDI	Class II	Unknown
DIOnavi. Profile Drill	GPD 6505	FDA UDI	Class I	Active
Dio Protem Implant System	MFB 25410	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAG 4810N	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3315S	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ETF 5013R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40704N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ACI 65302	FDA UDI	Class II	Unknown
UF(II) Eco Pickup Impression Coping	USPI 4806H	FDA UDI	Class I	Active
UF(II) Bar Holder Abutment Analog	MBHCAA 4512	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 40307H	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	SHN 2510	FDA UDI	Class II	Active
DIO Megagen Scan Adapter	SCAN 20[T]	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SASC 5806	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 4825(II)	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 6507	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 75257	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45607N	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45607H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	SHN 2010S	FDA UDI	Class II	Active

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