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 Implant System	UF 4007S<VerA>	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DACR 4555H	FDA UDI	Class II	Unknown
DIO Abutment Removing Driver	HARD 2025A	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSBA 3510	FDA UDI	Class II	Active
FTN Fixture Driver	HGC 5030	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 6815T(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMT 50631N	FDA UDI	Class II	Unknown
UF(II) Bar holder abutment	MBHCA 4508N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 452025N	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SASP 5810S	FDA UDI	Class II	Unknown
DIO Sinus Approach Initial Drill	SID 2013	FDA UDI	Class I	Active
UF(II) Implant System	MASC 2006	FDA UDI	Class II	Active
UF(II) H-Scan Body	MHSB 5005H	FDA UDI	Class I	Active
Pre-milled Bar	CBZR 01	FDA UDI	Class I	Active
DIO Megagen Scan Adapter	SCAN 20-15[H]	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 4060	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	IPI 48001	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 07	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45505H(II)	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 40604H	FDA UDI	Class II	Unknown
UF Implant System	UF(II) 5515S	FDA UDI	Class II	Unknown
UF(II) Profile Drill	UPD 5505M	FDA UDI	Class I	Active
UF(II) Narrow Transfer Impression Coping	UNSTI 4013H	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 75307	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DAUR 3555H	FDA UDI	Class II	Unknown
UF(II) Eco Base Abutment	USBA 5504N	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 11 A01	FDA UDI	Class I	Active
UF(II) Implant System	UNSSA 40404	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 65105	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	ACT 50645	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 65204H(II)	FDA UDI	Class II	Unknown
DIO Implant Systems	FTN 5013B	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPN 40512N	FDA UDI	Class II	Unknown
SM Transfer Impression Coping	ICC 4805-1	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	ACN 40535	FDA UDI	Class II	Unknown
SM Implant System	SFR 4512	FDA UDI	Class II	Unknown
SM-Extra Wide Implant System	MX 5910	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 40640N	FDA UDI	Class II	Unknown
SM Positioning Guide	PG 0060	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 40207H	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DLR 2570H	FDA UDI	Class II	Unknown
UV Active Implant System	UF(II) 4507UV3	FDA UDI	Class II	Active
UF(II) Fixture	UF(II) 6005S	FDA UDI	Class II	Active
Wax Denture	WDL 01	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSKA 4803	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DCN 1570H	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFP 20210	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	PMN 35310	FDA UDI	Class I	Active
FTN Tapered Drill	DTH 4015SM	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	RMI 48001	FDA UDI	Class II	Unknown

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