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 Biotite-H Implant Systems	SAC 5836N	FDA UDI	Class II	Unknown
DIO Guide Drill	GD 1836M	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 14 A02	FDA UDI	Class I	Active
UF(II) Implant System	UNSSA 40505	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 4510N	FDA UDI	Class II	Active
DIOnavi. Profile Drill	GPD 3005	FDA UDI	Class I	Active
DIO STEADY External Implant System	ESF 4013R	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 5847(II)	FDA UDI	Class II	Unknown
Dio Sm Implant System	SAHN 4138	FDA UDI	Class II	Unknown
UF(II) Eco Base Abutment	USBA 4802N	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 55404N(II)	FDA UDI	Class II	Active
FTN Fixture Mount	MAN 4007-1	FDA UDI	Class I	Active
UF(II) DA Protect Cap	DCLR 55	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 55405H(II)	FDA UDI	Class II	Active
DIO Steady External Implant System	ESF 4511R	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 4516SF	FDA UDI	Class II	Active
UF(II) Eco Base Abutment	USBA 6501H	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSHA 4560	FDA UDI	Class II	Active
DIO Dentium Pre-Milled Bar	CBSS 01D[H]	FDA UDI	Class I	Active
UF(II) Implant System	UNSSA 45307	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 5511SF	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSFA 4012	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 07 A03(a,b)	FDA UDI	Class I	Active
UF(II) Internal Solid Abutment Analog	RMI 60004N	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPI 65002G	FDA UDI	Class II	Unknown
Protem Surgical Kit	PRT 02	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCS 2730S	FDA UDI	Class II	Active
UF(II) Bar holder abutment	MBHA 4508N	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 55505H(II)	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSMUA 484020N	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAT 4810T	FDA UDI	Class II	Unknown
Cemented Abutment	AMI 35037N[H]	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSSA 45307	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFP 20410	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4508S	FDA UDI	Class II	Unknown
UF(II) Narrow Digital Lab Analog	DAU 3009	FDA UDI	Class I	Active
Dio Protem Implant System	MFB 25212	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFP 20414	FDA UDI	Class II	Unknown
DIOnavi. Guide Drill	UGD 2005RM	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UF(II)N 3011SF	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 3013DN	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	HCI 60704	FDA UDI	Class II	Unknown
DIO Fixture Removing Driver	FRD 11S<VerA>	FDA UDI	Class I	Active
UF(II) Implant System	UNSSA 40307	FDA UDI	Class II	Active
DIO Initial Drill	DHI 2014SM<VERA>	FDA UDI	Class I	Active
UFIII Fixture	UFIII 4513UV3	FDA UDI	Class II	Active
DIO Ball Abutment Driver	HD 2406A	FDA UDI	Class I	Active
DIO Multi Straight Abutment Holder	MSAH 4820	FDA UDI	Class I	Active
DIO Screw Driver	HD 1220A	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 35404	FDA UDI	Class II	Active

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