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) Narrow Implant System	UF(II)N 3308S	FDA UDI	Class II	Active
UF(II) Bar holder abutment	UNMBHA 4508N	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DALN 2570H	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 455025BH	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 4511S	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 553025AH	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 14 A03	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPT 5008	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65304N(II)	FDA UDI	Class II	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4510S	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45105H	FDA UDI	Class II	Unknown
DIOnavi. Initial Drill	ISD 2007N<VerA>	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSSA 45705	FDA UDI	Class II	Unknown
FTN Fixture Driver	HGC 5035	FDA UDI	Class I	Active
UF(II) Wide	UF(II) 6010SF	FDA UDI	Class II	Active
UF(II) Narrow Pick-up Impression Coping	UNSPI 4014H	FDA UDI	Class I	Active
UCLA Plastic Abutment	APN 35413[H]	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 5513SF	FDA UDI	Class II	Active
DIO Anyridge Pre-milled Bar	CBAR 01[H]	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 65405	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 04 A03	FDA UDI	Class I	Active
UF(II) Pick-up Impression Coping	SSPI 5509N	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 6524	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AHN 40508	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DAUN 1570N	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFB 20212	FDA UDI	Class II	Active
Secure Implant System(2.5/3.0mm)	MICP 3511	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSKA 4802	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40505H	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 55204H(II)	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 12 A01	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SASC 3908	FDA UDI	Class II	Unknown
FTN Tapered Drill	DTH 4508S	FDA UDI	Class I	Active
UF(II) Eco Pickup Impression Coping	USPI 4506N	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 45104	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	IPT 50612N	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 40105H	FDA UDI	Class II	Active
Protem Fixture Driver(Ratchet)	PBDH 3510	FDA UDI	Class I	Active
UF(II) Eco H-Scan Body	USHCD 4504H	FDA UDI	Class I	Active
FTN Pre-Milled Bar	CBEW 01[H]	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCS 2710	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 55555	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45404H	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DMR 3555H	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PSWF 6006S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPI 48004N	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DAUN 4570N	FDA UDI	Class II	Unknown
DIO Implant Systems	FTN 5010B	FDA UDI	Class II	Unknown
DIO STEADY External Implant System	ESF 3713R	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 45507N(II)	FDA UDI	Class II	Unknown

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