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
Protem Fixture Driver Assy	MGR 3510	FDA UDI	Class I	Active
Plastic Cylinder	API 48514[H]	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 75307H(II)	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 45305N	FDA UDI	Class II	Unknown
UF Implant System	PUF(II) 4008S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AHN 50602	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAI 35025A	FDA UDI	Class II	Unknown
Dio Sm Implant System	SSC 3110	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSMA 4015N	FDA UDI	Class II	Unknown
DIO Screw Driver	MD 1230	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AMN 35420N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 45455	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 5547	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 3208M	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45305H(II)	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 3718B	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 7834(II)	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SSC 1812H	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 453025BH	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCS 2720S	FDA UDI	Class II	Active
UF(II) Internal Pick-up Impression Coping	IPI 48008Y	FDA UDI	Class I	Active
DIO Implant Systems	FTT 5013B	FDA UDI	Class II	Unknown
DIO Zimmer Scan Adapter	SCAN 08-15[H]	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 75204	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45205H	FDA UDI	Class II	Active
DIO STEADY External Implant System	ETF 3315R	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 4835(II)	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 08 A01	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DCR 1570H	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 4844	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 4845T(II)	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65507N(II)	FDA UDI	Class II	Unknown
Mill Abutment	UNSMA 4530H	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SMA 4014T	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65507N(II)	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UF(II)N 3008S	FDA UDI	Class II	Active
UF(II) Narrow Protect Cap	UNSAC 4007	FDA UDI	Class I	Active
DIOnavi. Metal Needle Tip Extra Long	MNTE	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAS 3944	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65207N(II)	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFP 20212	FDA UDI	Class II	Active
DIO STEADY External Implant System	ESF 6011R	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	RMI 48005N	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PESF 3308R	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 06	FDA UDI	Class I	Active
DIO Steady External Implant System	PESF 3316R	FDA UDI	Class II	Unknown
DIO Sinus Approach Lateral Round Drill	SLRD 7004	FDA UDI	Class I	Active
DIO STEADY External Implant System	ESF 3711R	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 07 A02(a,b)	FDA UDI	Class I	Active
DIO Guide Sinus Approach Stopper	GST 05RD	FDA UDI	Class I	Active

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