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
Dio Protem Implant System	MFB 25214	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAH 6236	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAH 5235	FDA UDI	Class II	Unknown
UF(II) Implant System	MSA 4801	FDA UDI	Class II	Active
DIO Straight Drill	DSU 3808D	FDA UDI	Class I	Active
DIO Implant Systems	FSN 6013B	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSPI 4010H	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45705N	FDA UDI	Class II	Unknown
DIOnavi. Guide sleeve	GS 53GY	FDA UDI	Class I	Active
UF Implant System	UF 5007S<VerA>	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AGN 50604	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAN 35215	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 5864(II)	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAC 5844T	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PETF 6015R	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 45457	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSBA 3520	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 00 A03(a,b)	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 65105H(II)	FDA UDI	Class II	Active
UF(II) Eco Pickup Impression Coping	USNPI 4206H	FDA UDI	Class I	Active
Hybrid Link	UNHL 40552H	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAC 7505	FDA UDI	Class II	Unknown
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 4867(II)	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SASC 5804	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PESF 4515R	FDA UDI	Class II	Unknown
FTN H-Scan Body	EWHSB 641H	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	ITN 50612S	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	SHT 2008S	FDA UDI	Class II	Unknown
DIOnavi. Stopper	GST 2040YE	FDA UDI	Class I	Active
UF(II) Implant System	SSCS 3420S	FDA UDI	Class II	Active
DIO Implant System	PSI 6512P	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4008S	FDA UDI	Class II	Active
DIO Steady External Implant System	ETF 3713R	FDA UDI	Class II	Unknown
DIO STEADY External Implant System	ESF 3308R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45705H	FDA UDI	Class II	Active
DIO Implant System	FTN 4008B	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ITN 50612	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UF(II)N 3015S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AHN 35405	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DCR 1555N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSPI 6515H	FDA UDI	Class II	Unknown
DIO Implant Systems	FTN 5008B	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPN 3508N	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	SWF 6506S	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40704H	FDA UDI	Class II	Unknown
UF(II) Eco Digital Coping Screw	USCSC 1605H	FDA UDI	Class I	Active
DIO Zimmer Scan Adapter	SCAN 09-15[H]	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 7537	FDA UDI	Class II	Unknown
SM Implant System	SFR 5010	FDA UDI	Class II	Unknown
DIO UF HSA Internal Sub-Merged Implant System	PSWF 6510S	FDA UDI	Class II	Unknown

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