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
Cemented Abutment	AMN 40528N[H]	FDA UDI	Class II	Active
DIOnavi. Abutment Jig	AJ3D 02	FDA UDI	Class I	Active
DIOnavi. Initial Drill	ISD 2017	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DAUR 4555N	FDA UDI	Class II	Unknown
UF(II) Implant System	UNSSA 45707	FDA UDI	Class II	Active
UF(II) Narrow Transfer Impression Coping	UNSTI 4013N	FDA UDI	Class I	Active
UF(II) Anatomic abutment	DCR 2570N	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSCS 3410	FDA UDI	Class II	Active
UF Implant System	UF 5008S	FDA UDI	Class II	Unknown
UF(II) Implant System	SSHA 5520	FDA UDI	Class II	Active
DIOnavi. Tissue Punch	GTP 7124	FDA UDI	Class I	Active
DIO Solid Abutment Driver	HDS 4812A	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AHN 40504	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SIP 5813N	FDA UDI	Class II	Unknown
DIO Steady External Implant System	ESF 4515R	FDA UDI	Class II	Active
DIO UF HSA Internal Sub-Merged Implant System	PUF(II) 5515S	FDA UDI	Class II	Unknown
UF Implant System	UF 3810S	FDA UDI	Class II	Unknown
UF(II) Eco Base Abutment	USBA 6502N	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSCA 40305H	FDA UDI	Class II	Active
UF(II) Abutment Carrier	DJPR 00	FDA UDI	Class I	Active
DIO Steady External Implant System	ESF 6008R	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 2013M<VerA>	FDA UDI	Class I	Active
UFIII Fixture	UFIII 4013UV3	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DAUR 3555N	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 55205N(II)	FDA UDI	Class II	Active
DIOnavi. Guide (Anchor system)	GUIDE02 03 A03(a,b)	FDA UDI	Class I	Active
DIO UF HSA Internal Sub-Merged Implant System	PSWF 6508S	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSSA 45605	FDA UDI	Class II	Unknown
DIO Straight Drill	DSU 5010	FDA UDI	Class I	Active
DIO STEADY External Implant System	ESF 4515R	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	SSN 1403	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65407N(II)	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSSA 45404	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSBA 3570	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 75204N(II)	FDA UDI	Class II	Unknown
DIO Reverse Cutting Drill	RCD 36	FDA UDI	Class I	Active
UF(II) Implant System	SSSA 65204	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AHN 50602	FDA UDI	Class II	Active
UF(II) Eco Cemented Post	USP 5507H	FDA UDI	Class II	Active
UF(II) Narrow Implant System	UNSHA 4035	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AHI 48601H	FDA UDI	Class II	Active
UF(II) Implant System	SSCA 45104H(II)	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAC 5507	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UF(II)N 3013SF	FDA UDI	Class II	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAS 6834(II)	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	RMI 48012	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 08 A01(a,b)	FDA UDI	Class I	Active
DIO Guide Sinus Approach Stopper	GST 10YE	FDA UDI	Class I	Active
Dio Sm-Extra Wide(rbm) Implant Systems	SAC 5835T(II)	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 45305H	FDA UDI	Class II	Unknown

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