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
UF(II) Scan Adapter	SCAN 682H	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 55404H(II)	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAC 7504	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AMN 35419N	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 6824T(II)	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF 4515S	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 5510N	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 7865(II)	FDA UDI	Class II	Unknown
DIO External Guide	EXT 27	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	UF 5011S	FDA UDI	Class II	Unknown
DIO Strauman Pre-Milled Bar	CBITR 01[H]	FDA UDI	Class I	Active
UF(II) Wide	UF(II) 6013SF	FDA UDI	Class II	Unknown
UF(II) Internal Tap Drill	UITD 3615	FDA UDI	Class I	Active
DIOnavi Guide	GUIDE 02 A04(a,b)	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 55507	FDA UDI	Class II	Active
DIOnavi-Denture02	3DDEN02-100P1	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AHN 35405	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 551515AH	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 6010B	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PESF 3315R	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 55404	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	SSN 2003	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DAUR 1555N	FDA UDI	Class II	Unknown
UF(II) Narrow Guide Pin	UNSSG 1422	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPN 3508	FDA UDI	Class I	Active
UF(II) Implant System	MSA 4803	FDA UDI	Class II	Active
UFIII Fixture	UFIII 5008UV3	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 451515AH	FDA UDI	Class II	Active
DIOnavi-Denture02	3DDEN02-100A4	FDA UDI	Class II	Unknown
UF(II) Implant System	UF(II) 3816S	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AHN 35406	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 40528	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 555025N	FDA UDI	Class II	Active
UF(II) Eco Base Abutment	USBA 6505H	FDA UDI	Class II	Active
DIO UF HSA Internal Sub-Merged Implant System	UF 3816S	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PETF 3710R	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 4015B	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSPI 6510N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 65404	FDA UDI	Class II	Unknown
DIOnavi. Initial Drill	ISD 2007<VerA>	FDA UDI	Class I	Active
FTN Surgical Kit	FTN 02-M	FDA UDI	Class I	Active
UF(II) Implant System	UNSSA 45104	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	IPN 40510	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 2715DN	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAC 5505	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 45305N	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 55207H(II)	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DCR 4570H	FDA UDI	Class II	Unknown
DIO Implant Systems	FSN 5508B	FDA UDI	Class II	Unknown
DIO Implant System	IFI 6514PM	FDA UDI	Class II	Unknown

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