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	AEI 48017	FDA UDI	Class II	Unknown
DIOnavi. Drill Tube	UDT 25	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45504H(II)	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AAN 35415	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	HCN 40504	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DMR 2570N	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SMA 6015T	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 4013S	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSSA 45604	FDA UDI	Class II	Unknown
DIOnavi. Implant Connector	GWICC 6808	FDA UDI	Class I	Active
UF Implant System	SWF 7012S	FDA UDI	Class II	Unknown
UF(II) Internal Solid Abutment Analog	RMI 60007N	FDA UDI	Class I	Active
DIO Guide Sinus Approach Stopper	GST 03BL	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 55304H(II)	FDA UDI	Class II	Active
DIOnavi. Implant Connector	GNIC 3609ST	FDA UDI	Class I	Active
DIO Fixture Driver assy (Ratchet)	FDW 3506A<VerF>	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 4505	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 65507	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 3916T	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45304H	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AMI 48434EX	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 5510SF	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	SHN 2509	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	TMN 35412N	FDA UDI	Class II	Unknown
UF(II) Eco Cemented Post	USP 5505H	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 45454	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAT 50225	FDA UDI	Class II	Active
DIO Implant Systems	IFI 5508PM	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3310SF	FDA UDI	Class II	Active
DIO Screw Remove	SR 32	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 2718DN	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCS 2710S	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 555015BH	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3008S	FDA UDI	Class II	Unknown
UF(II) Eco Transfer Impression Coping	USTI 4510N	FDA UDI	Class I	Active
DIO Implant Systems	IFI 4808M	FDA UDI	Class II	Unknown
UV Active Implant System	UF(II) 6510UV3	FDA UDI	Class II	Active
DIO UF HSA Internal Sub-Merged Implant System	PSWF 7012S	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 4816T	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 5234	FDA UDI	Class II	Unknown
UF(II) Wide	UF(II) 7007S	FDA UDI	Class II	Unknown
DIO Sinus Lift Kit	SLK 01	FDA UDI	Class I	Active
DIO Implant System	IFI 3510PM	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DALR 4570H	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 2519DN	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAS 5238	FDA UDI	Class II	Unknown
UF(II) Internal Count Sinker	CSUI 5025	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DPR 2555H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMI 48437EX	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45605N	FDA UDI	Class II	Active

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