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
Angled Abutment	AAN 50425[H]	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	ITT 50612S	FDA UDI	Class II	Unknown
UF(II) Eco Cemented Post	USP 4805N	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSSA 45304	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PESF 5013R	FDA UDI	Class II	Unknown
FTN Guide Pin	PCN 40310S	FDA UDI	Class I	Active
UF(II) Angled Path Pin	DAP 4515B	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAA 48125	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 2708D	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3018DN	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSPI 4515H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAT 50215	FDA UDI	Class II	Unknown
FTN H-Scan Body	ENHSB 461H	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 45504H	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAA 39325A	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PESF 3311R	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 75507	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 45154	FDA UDI	Class II	Unknown
DIO Implant Systems	FST 5010B	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 5011S	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75205H(II)	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 3211M	FDA UDI	Class I	Active
UF(II) Implant System	UF(II) 3816SF	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAN 50415	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 4040	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMT 50628N	FDA UDI	Class II	Unknown
DIO Implant System	PSI 4008P	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	SHN 2008S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPI 48002B	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 451525N	FDA UDI	Class II	Unknown
UF(II) Scan Adapter Screw	SSCAN 2015H	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SIT 4810T	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 4011SF	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 40620	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 3968	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 6865T(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMT 50628	FDA UDI	Class II	Unknown
Dio Protem Implant System	MFP 25208	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45204H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AGN 40504N	FDA UDI	Class II	Unknown
DIO Fixture Driver assy (Ratchet)	FDW 3518A<VerF>	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 04 A04(a,b)	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 5504	FDA UDI	Class I	Active
DIOnavi. Straight Drill	MSD 1518D	FDA UDI	Class I	Active
DIO Solid Abutment Driver	HD 3506A	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 12	FDA UDI	Class I	Active
DIO Scan Adapter	SCAN 14-15[H]	FDA UDI	Class I	Active
UF Implant System	PSWF 6510S	FDA UDI	Class II	Unknown
DIO H-Scan Body	ITHSB 581	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DMR 1540H	FDA UDI	Class II	Unknown

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