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
FTN Tapered Drill	DTH 3310S	FDA UDI	Class I	Active
UF(II) Internal Tap Drill	UITD 4515	FDA UDI	Class I	Active
UF(II) Eco H-Scan Body	USHCD 4804H	FDA UDI	Class I	Active
UF(II) Fixture	UF(II) 6505SF	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 6815(II)	FDA UDI	Class II	Unknown
UF(II) Bar holder abutment	UNMBHCA 4507N	FDA UDI	Class II	Active
UF(II) Eco Coping Screw	USTISC 1609H	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 45604N	FDA UDI	Class II	Active
UF(II) Wide	UF(II) 7013SF	FDA UDI	Class II	Active
DIO H-Scan Body	ITHSB 441	FDA UDI	Class I	Active
DIO Steady External Implant System	PETF 5015R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45304H	FDA UDI	Class II	Unknown
Secure Implant System	MFP 30412A	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40605H	FDA UDI	Class II	Active
DIO Steady External Implant System	PETF 3313R	FDA UDI	Class II	Unknown
DIO Biotite-H Implant System	SFN 4110H	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAP 5510B	FDA UDI	Class I	Active
DIOnavi. Tap Drill	GTD 6515DW	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 45504	FDA UDI	Class II	Unknown
FTN Scan Adapter	SCAN 21-15[H]	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DUN 2555H	FDA UDI	Class II	Active
DIO STEADY External Implant System	ESF 5016R	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AHN 40502	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 3816SF	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSMUA 482520H	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 4013SF	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAC 6505	FDA UDI	Class II	Active
FTN Tapered Drill	DTH 4013S	FDA UDI	Class I	Active
UV Active Implant System	UF(II) 5011UV3	FDA UDI	Class II	Active
DIOnavi. Guide (Anchor system)	GUIDE02 08 A03(a,b)	FDA UDI	Class I	Active
DIOnavi. Stopper	GST 2060BL	FDA UDI	Class I	Active
DIO Steady External Implant System	ESF 3308R	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 2710D	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DAUN 2570N	FDA UDI	Class II	Unknown
UF(II) Eco Base Abutment	USBA 4803N	FDA UDI	Class II	Active
FTN Pre-milled Bar	CBEN 02	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSSA 40404	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAI 35015	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 5511S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AHI 48604H	FDA UDI	Class II	Active
DIOnavi. Tissue Punch	GTP 3430<TIN>	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAC 3924T	FDA UDI	Class II	Unknown
DIO Implant System	IFI 3508PM	FDA UDI	Class II	Unknown
DIO STEADY External Implant System	ETF 3310R	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 4814N(II)	FDA UDI	Class II	Unknown
FTN H-Scan Body	EWHSB 681H	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	UF 5008S	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PETF 3311R	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 3013	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 40107H	FDA UDI	Class II	Active

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