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) Internal Transfer Impression Coping	ITI 60010N	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45404H(II)	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSOA 6055	FDA UDI	Class II	Unknown
DIOnavi. Point Straight Drill	PSD 2518	FDA UDI	Class I	Active
DIO STEADY External Implant System	ESF 3708R	FDA UDI	Class II	Unknown
FTN Fixture Mount Screw	STN 2507H	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4516S	FDA UDI	Class II	Unknown
DIO Slot Driver	HD 0610A	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPN 5008	FDA UDI	Class I	Active
Hybrid Link	UNHL 40553H	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 55105N(II)	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 5844T(II)	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 4865T(II)	FDA UDI	Class II	Unknown
FTN Tapered Drill	DTH 4008SM	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 5515N	FDA UDI	Class II	Unknown
Bone Expander	BEP 1737	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 5513SF	FDA UDI	Class II	Unknown
UF Implant System	SWF 7006S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	HMI 48557	FDA UDI	Class II	Active
DIO STEADY External Implant System	ETF 6013R	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ITN 35412	FDA UDI	Class II	Unknown
Secure Implant System	MFB 30212A	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 5825(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPI 48008	FDA UDI	Class II	Unknown
DIO STEADY External Implant System	ESF 6010R	FDA UDI	Class II	Unknown
Protem Tissue Punch	MTP 3010	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DACR 4570H	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 75107	FDA UDI	Class II	Unknown
Secure Implant System	MFP 30214A	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	SWF 7012S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AEI 48037N	FDA UDI	Class II	Unknown
Dio Implant Systems	IPI 35008	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45404H	FDA UDI	Class II	Unknown
UF Implant System	PSWF 6014S	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSAA 404015N	FDA UDI	Class II	Unknown
DIOnavi. Initial Drill	ISD 2008<VerA>	FDA UDI	Class I	Active
DIO Osstem Pre-Milled Bar	CBOM 01[H]	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	ACT 50634	FDA UDI	Class II	Unknown
DIO Internal Fixture Removing Driver	FRD 8L	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAT 5810N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAA 48115	FDA UDI	Class II	Unknown
Secure Implant System	MFB 30210A	FDA UDI	Class II	Unknown
DIOnavi. Anchor sleeve	ASL 20	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DMR 4540H	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3013S	FDA UDI	Class II	Active
UF Fixture Mount	UFM 45815	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 65504H(II)	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 6507	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DLN 3555N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55207H(II)	FDA UDI	Class II	Unknown

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