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 Internal/External Implant Systems	AMN 50628N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	RCN 50512	FDA UDI	Class II	Unknown
DIO Fixture Driver assy (Machine)	FDC 3512<VerF>	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DUN 4555H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AAT 50225	FDA UDI	Class II	Active
UF(II) DA Protect Cap	DCCR 70	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 2517DN	FDA UDI	Class I	Active
UF(II) Fixture	UF(II) 4505S	FDA UDI	Class II	Active
Secure Implant System(2.5/3.0mm)	MCA 4011	FDA UDI	Class II	Active
DIO Sinus Trephine Drill	STD 4030	FDA UDI	Class I	Active
UF(II) Bar Holder Abutment Clip	MBHC 1525P	FDA UDI	Class I	Active
UF(II) Wide	UF(II) 6511SF	FDA UDI	Class II	Active
UF(II) Implant System	UNSSA 45607	FDA UDI	Class II	Active
DIO Depth Gauge	DPG 2050	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 55355	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3315S	FDA UDI	Class II	Active
DIO Implant Systems	PSI 4012	FDA UDI	Class II	Unknown
UF(II) Profile Drill	UPD 3805M	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3019DN	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 7865T(II)	FDA UDI	Class II	Unknown
Dio Implant Systems	ABN 50505	FDA UDI	Class II	Unknown
DIOnavi. Straight Drill	USD 2718N	FDA UDI	Class I	Active
DIO Implant Systems	PSI 3514P	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSTA 4510H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	HMI 48554	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 45255	FDA UDI	Class II	Unknown
DIOnavi. Guide sleeve	GS 53BLSET	FDA UDI	Class I	Active
DIOnavi. Surgical Guide	GUIDE 01 A02	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSSA 55157	FDA UDI	Class II	Unknown
FTN Tapered Drill	DTH 4008SD	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAA 39125B	FDA UDI	Class II	Unknown
Veltz-C&B	3DCNB-1000A2<VerA>	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSHA 5013	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40305N	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AHN 40606	FDA UDI	Class II	Active
DIO STEADY External Implant System	ESF 6008R	FDA UDI	Class II	Unknown
DIO H-Scan Body	ITHSB 461	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 65207	FDA UDI	Class II	Active
UF(II) Implant System	UNSSA 40605	FDA UDI	Class II	Active
UF(II) Pick-up Impression Coping	SSPI 6513H	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAC 4826T	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 5505	FDA UDI	Class II	Unknown
UF(II) Scan Adapter	MSCAN 4808H	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SAC 4866T	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSAA 402015AH	FDA UDI	Class II	Unknown
DIO Steady External Implant System	PETF 4015R	FDA UDI	Class II	Unknown
UF(II) Eco Cemented Post	USP 6504H	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 3815S	FDA UDI	Class II	Active
UF(II) H-Scan Body Jig	JIG 602	FDA UDI	Class I	Active
DIO Implant System	IFI 3512PM	FDA UDI	Class II	Unknown

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