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 Reverse Cutting Drill	RCD 32	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	IOTI 60010	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 4815	FDA UDI	Class I	Active
FTN Fixture Driver	HGC 3520	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 40503	FDA UDI	Class II	Active
FTN Fixture Mount Screw	STN 2007H	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSTA 4010N	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ETF 4516R	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 65307	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	TMT 50612	FDA UDI	Class II	Unknown
UF(II) Eastab Cylinder	ESMC 4806H	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	IPN 50608	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3205	FDA UDI	Class I	Active
UF(II) Eco Base Abutment	USBA 4503N	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	ITI 48010S	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 3618	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AHN 50604	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSPI 4510N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAT 4810N	FDA UDI	Class II	Unknown
DIOnavi. Guide sleeve	GS 53	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SSG 1815	FDA UDI	Class II	Unknown
DIO Lateral Core Drill	SLCD 5504	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 45707H	FDA UDI	Class II	Unknown
DIO STEADY External Implant System	ETF 5011R	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 5008B	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 4080	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 65357	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 451515BH	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 65555	FDA UDI	Class II	Unknown
DIO Implant System	PSI 6508P	FDA UDI	Class II	Unknown
DIO Guide Sinus Approach Stopper	GST 06BL	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3815M	FDA UDI	Class I	Active
UF(II) Eco Transfer Impression Coping	USTI 6510N	FDA UDI	Class I	Active
DIOnavi. Abutment Jig	AJ3D 03N	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DUN 3555N	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 3215M	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DUN 1570N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 6515S	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 3808S	FDA UDI	Class II	Unknown
UF(II) Implant System	UNSSA 40305	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 45704N	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 45204N(II)	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 3307B	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65404N(II)	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DALN 5555H	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFB 25408	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF 4007S	FDA UDI	Class II	Unknown
UV Active Implant System	UF(II)N 3008UV3	FDA UDI	Class II	Active
Dio Implant Systems	ABN 40505	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ITN 35412S	FDA UDI	Class I	Active

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