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) Internal Positioning Cylinder	IPI 65002B	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45407H(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	RMI 48005N	FDA UDI	Class I	Active
UF Implant System	UF(II) 4511S	FDA UDI	Class II	Unknown
DIO Implant Systems	FTN 5513B	FDA UDI	Class II	Unknown
DIO Open Wrench	OW 004	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 4864N(II)	FDA UDI	Class II	Unknown
UF(II) Pick-up Impression Coping	SSPI 4519H	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAS 5818	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAT 50215	FDA UDI	Class II	Active
Dio Protem Implant System	MFB 20214	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 3008DN	FDA UDI	Class I	Active
DIO Fixture Driver assy (Ratchet)	FDW 3512A<VerF>	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 75104	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 5864N(II)	FDA UDI	Class II	Unknown
DIOnavi. Connector Extension	CE 6512M	FDA UDI	Class I	Active
UV Active Implant System	UF(II) 4010UV3	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 55504	FDA UDI	Class II	Active
UF(II) Eco Base Abutment	USBA 4804H	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	ACT 50634	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 453015AH	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	TCN 40512N	FDA UDI	Class II	Active
DIOnavi. Guide	GUIDE02 09(a,b)	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 454015AH	FDA UDI	Class II	Active
FTN Tapered Drill	DTH 3315SM	FDA UDI	Class I	Active
UF Implant System	UF 4010S<VerA>	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4018S	FDA UDI	Class II	Active
Dio Protem Implant Systems	MAB 2510	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UF(II)N 3011S	FDA UDI	Class II	Active
UFIII Fixture	UFIII 4511UV3	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 3016DN	FDA UDI	Class I	Active
FTN Fixture Mount	EMW 51210[T]	FDA UDI	Class I	Active
DIOnavi. Abutment Jig	AJ3D 03H	FDA UDI	Class I	Active
DIOnavi. Guide	GUIDE02 12(a,b)	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSBA 3520	FDA UDI	Class II	Active
Dio Protem Implant System	MFB 20408	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 3810S	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAS 4236	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 3614	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 3817	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 45205H(II)	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 3210	FDA UDI	Class I	Active
Plastic Cylinder	API 48514N[H]	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DACR 2555N	FDA UDI	Class II	Unknown
UF(II) DA Protect Cap	DCMR 55	FDA UDI	Class I	Active
DIOnavi. Abutment Profile Drill	UAPD 5124<VerA>	FDA UDI	Class I	Active
UF(II) H-Scan Body Jig	JIG 401	FDA UDI	Class I	Active
UF(II) Multi Cylinder Protector	MCP 4804	FDA UDI	Class I	Active
DIO Megagen Scan Adapter	SCAN 20[H]	FDA UDI	Class I	Active
SM Implant System	SFR 4508	FDA UDI	Class II	Unknown

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