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) Implant System	UF(II) 4515SF	FDA UDI	Class II	Active
Dio Uf Hsa Internal Sub-Merged Implant System	SSTI 4010H	FDA UDI	Class II	Active
DIOnavi. Surgical Guide	GUIDE 10 A02	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DUN 2555N	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSSA 40507	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65307H(II)	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 05 A04(a,b)	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3211	FDA UDI	Class I	Active
UF(II) Eco Cemented Post	USP 6505H	FDA UDI	Class II	Active
DIO Steady External Implant System	PETF 5008R	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ITT 50612	FDA UDI	Class I	Active
UF(II) Implant System	UNSSA 45305	FDA UDI	Class II	Active
UF(II) Implant System	SSSA 65407	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 4305	FDA UDI	Class I	Active
UF(II) Narrow Implant System	UNSSA 45707	FDA UDI	Class II	Unknown
DIO Biotite-H Implant System	SFW 5308H	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	IPI 60710N	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 04	FDA UDI	Class I	Active
DIO Guide Sinus Approach Stopper	LST 15BL	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	CHN 4001	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPI 48610N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65507H(II)	FDA UDI	Class II	Unknown
DIOnavi. Guide	GUIDE02 06(a,b)	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DPR 3540H	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 10 A01(a,b)	FDA UDI	Class I	Active
UF Implant System	SWF 6514S	FDA UDI	Class II	Unknown
DIO Implant Systems	IFI 5512PM	FDA UDI	Class II	Unknown
DIO Screw Driver Ratchet Wrench (Nobel)	WHD 0915A	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 65404H(II)	FDA UDI	Class II	Unknown
Healing Cap	HCI 65704[H]	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 65205H(II)	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 04 A02	FDA UDI	Class I	Active
Dio Protem Implant Systems	MAP 3010	FDA UDI	Class I	Active
UF(II) DA Protect Cap	DACUR 70	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AMN 40542N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	IPI 48001	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55304H(II)	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 04 A05	FDA UDI	Class I	Active
UF(II) Fixture	UF(II) 7005SF	FDA UDI	Class II	Active
DIOnavi. Straight Drill	USD 4316	FDA UDI	Class I	Active
Dio Biotite-H Implant Systems	SSG 1810	FDA UDI	Class II	Unknown
DIO Implant System	PSI 4814	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 45204	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSSA 40607	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55305N(II)	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SIT 3910T	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCS 3400S	FDA UDI	Class II	Unknown
UF(II) Anatomic abutment	DACR 1555N	FDA UDI	Class II	Unknown
UF(II) Wide	UF(II) 6010S	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 3634	FDA UDI	Class II	Unknown

DIO Corporation

What DIO Corporation makes

Frequently asked questions

Information

Catalogue (5538)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities