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 Protem Implant System	MFP 20214	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PETF 4511R	FDA UDI	Class II	Unknown
UF(II) Narrow Transfer Impression Coping	UNSTI 4015N	FDA UDI	Class I	Active
UF(II) Internal Count Sinker	CSUI 5020	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 65407	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PESF 5015R	FDA UDI	Class II	Unknown
Dio Protem Implant Systems	MAP 3010	FDA UDI	Class II	Unknown
UF(II) Fixture	UF(II) 4505SF	FDA UDI	Class II	Active
DIO Biotite-H Implant System	SFN 3810H	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 4524	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	ICC 48588N	FDA UDI	Class II	Unknown
DIOnavi. Profile Drill	GPD 7005	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	PMN 50315	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 35439	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SIT 3910S	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ETF 4013R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSAA 404015AH	FDA UDI	Class II	Unknown
UF(II) Wide	UF(II) 7007SF	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAN 40215	FDA UDI	Class II	Active
DIO Straight Drill	DSU 3810M	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DALR 5570N	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 3710B	FDA UDI	Class II	Unknown
FTN Counter Sinker	NCS 5108	FDA UDI	Class I	Active
Dio Protem Implant System	MFB 25210	FDA UDI	Class II	Unknown
UF(II) Bar holder abutment	MBHCA 4507N	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DPR 2555N	FDA UDI	Class II	Unknown
UF(II) Implant System	UNSSA 45404	FDA UDI	Class II	Active
UF(II) Internal Plastic Coping	IPI 60004	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DCN 1555N	FDA UDI	Class II	Unknown
UF(II) Narrow Fixture Driver Contra Angle	UNFDC 3006	FDA UDI	Class I	Active
DIO Implant System	IFI 4008M	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 11 A01(a,b)	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DCR 3555H	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3308SF	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	ICC 48508N	FDA UDI	Class II	Active
DIOnavi. Guide (Anchor system)	GUIDE02 01 A05(a,b)	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 452015BH	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 65354	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55504N(II)	FDA UDI	Class II	Active
DIO Osteotome Kit	OST 01	FDA UDI	Class I	Active
DIO STEADY External Implant System	ETF 4511R	FDA UDI	Class II	Unknown
UF(II) Eco Base Abutment	USBA 5502N	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 4810DW	FDA UDI	Class I	Active
DIO Straight Drill	DSU 3013D	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAC 3934T	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 6835(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ACI 48302	FDA UDI	Class II	Active
UF(II) Bone Profile Drill	BPD 4616GN	FDA UDI	Class I	Active
Dio Protem Implant System	MFB 25212	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 5008SF	FDA UDI	Class II	Unknown

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