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 Pick-up Impression Coping	SIP 5810T	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 5510H	FDA UDI	Class II	Active
UF Implant System	UF(II) 4510S	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 2708DW	FDA UDI	Class I	Active
DIOnavi. Stopper	GST 2030BL	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSCA 40605H	FDA UDI	Class II	Unknown
DIOnavi. Implant Connector	GNIC 3618	FDA UDI	Class I	Active
DIO Straight Drill	DSU 3813M	FDA UDI	Class I	Active
DIOnavi. Guide (Anchor system)	GUIDE02 02 A03(a,b)	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	ICC 60649N	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DCR 3570N	FDA UDI	Class II	Unknown
UF(II) Implant System	UCA 4803	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	TMN 35412	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	PMN 50310	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 14 A02(a,b)	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4510S	FDA UDI	Class II	Active
DIO STEADY External Implant System	ETF 5010R	FDA UDI	Class II	Unknown
UF Implant System	UF 5010S	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPI 65002G	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 554025AH	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 3019	FDA UDI	Class I	Active
DIOnavi. Guide Sleeve	GSL 36YE_50	FDA UDI	Class I	Active
DIO Zimmer Pre-Milled Bar	CBZR 01[H]	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 4865(II)	FDA UDI	Class II	Unknown
UF(II) Bar holder abutment	UNMBHA 4509N	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAH 4024T	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 3210D	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	ABN 35503	FDA UDI	Class II	Unknown
DIO Multi Screw Driver	MSD 1430	FDA UDI	Class I	Active
UF Implant System	SWF 6508S	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 5866	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSAA 402015AH	FDA UDI	Class II	Active
DIO STEADY External Implant System	ETF 3708R	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DUN 4570H	FDA UDI	Class II	Unknown
DIO STEADY External Implant System	ESF 3313R	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 4513	FDA UDI	Class II	Active
UF(II) DA Protect Cap	DCCR 70G	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DUN 1555H	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45505H	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DPR 4570N	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSHA 4020	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DAUR 4570N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 4060	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PESF 5016R	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 455015N	FDA UDI	Class II	Active
DIO UF HSA Internal Sub-Merged Implant System	UF(II) 4513S	FDA UDI	Class II	Active
UF Implant System	UF 4516S	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 5507DW	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3015	FDA UDI	Class I	Active
UF(II) Profile Drill	UPD 7010	FDA UDI	Class I	Active

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