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 Implant Systems	IFI 4012PM	FDA UDI	Class II	Unknown
UV Active Implant System	UF(II) 3808UV3	FDA UDI	Class II	Active
DIO Screw Driver	HD 1205A	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	ACN 50612	FDA UDI	Class II	Active
UF(II) DA Protect Cap	DCLR 70	FDA UDI	Class I	Active
UF(II) Pick-up Impression Coping	SSPI 4513H	FDA UDI	Class I	Active
UF(II) Bar holder abutment	MBHCA 4506N	FDA UDI	Class II	Unknown
DIO Implant Systems	FTT 5015B	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 2515DN	FDA UDI	Class I	Active
DIOnavi. Profile Drill	GPD 4005M	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 5515H	FDA UDI	Class II	Unknown
DIO Sinus Approach Round Drill	SRD 2813	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 55504	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 451525BH	FDA UDI	Class II	Active
DIO Screw Driver	HD 1725A	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 40602	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 4515H	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AMT 50631	FDA UDI	Class II	Unknown
Angled Abutment	AAN 40215[H]	FDA UDI	Class II	Active
DIO Fixture Removing Driver	FRD 11L	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3213M	FDA UDI	Class I	Active
DIO Implant Systems	IFI 4012M	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 35442	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 4535	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	IPN 3508N	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 55204N(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAI 35025B	FDA UDI	Class II	Unknown
Dio Protem Implant Systems	MBC 3803	FDA UDI	Class II	Unknown
FTN Guide Pin	PCN 40315S	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPN 40510N	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSBA 3540	FDA UDI	Class II	Unknown
DIO STEADY External Implant System	ETF 4010R	FDA UDI	Class II	Unknown
DIO Implant Systems	FTN 4011B	FDA UDI	Class II	Unknown
UF(II) Pick-up Impression Coping	MPI 4811H	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 55204H(II)	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 7835N(II)	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 4015H	FDA UDI	Class II	Unknown
FTN Tapered Drill	DTH 3311S	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 5518S	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSPI 5515N	FDA UDI	Class II	Unknown
DIO Scan Adapter Screw	SSC 2508	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SABA 3510	FDA UDI	Class I	Active
UF(II) Wide	UF(II) 6508S	FDA UDI	Class II	Unknown
Secure Implant System(2.5/3.0mm)	MICP 3511	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAC 5505	FDA UDI	Class II	Unknown
DIO Implant Systems	IFI 4808PM	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 35417	FDA UDI	Class II	Unknown
DIO Fixture Driver assy (Machine)	FDC 3506<VerF>	FDA UDI	Class I	Active
DIO Multi Angled Abutment Holder	MAH 1629	FDA UDI	Class I	Active
UF Implant System	UF 3811S<VerA>	FDA UDI	Class II	Unknown

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