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
Sm Internal/External Implant Systems	IPN 40508	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AHT 50604	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75207N(II)	FDA UDI	Class II	Active
UF(II) Narrow Pre-Milled Bar	CBUN 01	FDA UDI	Class I	Active
UV Active Implant System	UF(II) 4011UV3	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSSA 40504	FDA UDI	Class II	Unknown
UCLA Plastic Abutment	APN 40513[H]	FDA UDI	Class II	Active
UF(II) Eco Base Abutment	USBA 5505N	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AGN 40514N	FDA UDI	Class II	Unknown
UF(II) Wide	UF(II) 6008SF	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 55357	FDA UDI	Class II	Unknown
DIO STEADY External Implant System	ESF 4008R	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 5018S	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 4814T	FDA UDI	Class II	Unknown
Secure Implant System(2.5/3.0mm)	MCA 4011	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 75457	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSMUA 485020H	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSGA 4530N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 5814T	FDA UDI	Class II	Unknown
UF(II) Eco Base Abutment	USBA 5502H	FDA UDI	Class II	Active
DIO Sinus Approach Stopper	ST 04YE	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 45105N	FDA UDI	Class II	Active
FTN Pre-Milled Bar	CBEW 02[H]	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 11 A04	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 50606	FDA UDI	Class II	Active
DIOnavi. Abutment Profile Drill	UAPD 5126	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 2510DN	FDA UDI	Class I	Active
DIO Straight Drill	DSU 2018M<VerA>	FDA UDI	Class I	Active
DIO Straight Drill	DSU 4318M	FDA UDI	Class I	Active
DIOnavi. Straight Drill	MSD 1514D	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DLR 2555H	FDA UDI	Class II	Unknown
UF(II) DA Protect Cap	DCUR 55	FDA UDI	Class I	Active
UF(II) Eco Cemented Post	USP 4505H	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DUR 4555N	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40207H	FDA UDI	Class II	Unknown
FTN Tapered Drill	DTH 4511SM	FDA UDI	Class I	Active
DIO Implant System	PSI 4814P	FDA UDI	Class II	Unknown
DIO Implant System	PSI 4008	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ACN 40513	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DACR 2570H	FDA UDI	Class II	Unknown
UF(II) Eco Cemented Post	USP 4507H	FDA UDI	Class II	Active
Multi Angled Abutment	MAA 483530H	FDA UDI	Class II	Active
Protem Fixture Driver	MGC 3415	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	API 48514	FDA UDI	Class II	Active
UV Active Implant System	UF(II) 5513UV3	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	RT 0502	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 3007	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 555025BH	FDA UDI	Class II	Unknown
UF(II) Straight Drill	SDS 2715BD	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 55204N(II)	FDA UDI	Class II	Active

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