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) Wide	UF(II) 6513SF	FDA UDI	Class II	Unknown
UF(II) Implant System	SSSA 45407	FDA UDI	Class II	Unknown
DIOnavi. Surgical Guide	GUIDE 01 A05	FDA UDI	Class I	Active
DIOnavi. Straight Drill	USD 3011DN	FDA UDI	Class I	Active
UF(II) Fixture	UF(II) 4005SF	FDA UDI	Class II	Active
UF(II) Implant System	UF(II) 3811SF	FDA UDI	Class II	Unknown
UF(II) Fixture	UF(II) 5505S	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	AAN 40425	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SAS 5826	FDA UDI	Class II	Unknown
DIO Drill Stopper	ST 4009	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	AAN 50215	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	ITN 40512	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCS 2730S	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSCA 40405H	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ACN 50612	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 4828	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ITT 50612H	FDA UDI	Class I	Active
Dio Uf Hsa Internal Sub-Merged Implant System	STI 2004	FDA UDI	Class II	Active
UF(II) Anatomic abutment	DACR 2555H	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 453025AH	FDA UDI	Class II	Unknown
DIO STEADY External Implant System	ETF 4508R	FDA UDI	Class II	Unknown
UF(II) Narrow Implant System	UNSSA 45607	FDA UDI	Class II	Unknown
DIOnavi-Cast02	3DCAST02-1000	FDA UDI	Class I	Active
UF(II) Implant System	SSCA 55107N(II)	FDA UDI	Class II	Active
UF(II) Eco Guide Pin	USPISC 1410H	FDA UDI	Class I	Active
Secure Implant System	MFP 30410A	FDA UDI	Class II	Active
Sm Internal/External Implant Systems	APN 40514N	FDA UDI	Class II	Unknown
DIOnavi-C&B Z	3DCNBF-1000B4	FDA UDI	Class I	Active
DIO Implant Systems	FTN 5508B	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	TMT 50612N	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	ITN 40512	FDA UDI	Class I	Active
DIO Straight Drill	DSU 3815D	FDA UDI	Class I	Active
DIO Steady External Implant System	PESF 3715R	FDA UDI	Class II	Unknown
UF(II) Implant System	SSCA 65307N(II)	FDA UDI	Class II	Active
DIOnavi. Anchor Screw	ASC 1516	FDA UDI	Class I	Active
UF(II) Wide	UF(II) 7011S	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSAA 551525BH	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSPI 5510H	FDA UDI	Class II	Unknown
UF(II) Internal Count Sinker	CSUI 5525	FDA UDI	Class I	Active
Sm Internal/External Implant Systems	IPN 40512	FDA UDI	Class I	Active
DIO STEADY External Implant System	ETF 6016R	FDA UDI	Class II	Unknown
UF Implant System	PSWF 6008S	FDA UDI	Class II	Unknown
DIO Implant Systems	PSI 3510P	FDA UDI	Class II	Unknown
Sm Internal/External Implant Systems	AMN 40520N	FDA UDI	Class II	Unknown
Dio Implant Systems	AMI 35027	FDA UDI	Class II	Unknown
Dio Biotite-H Implant Systems	SAS 5218	FDA UDI	Class II	Unknown
Dio Uf Hsa Internal Sub-Merged Implant System	SSPI 4510H	FDA UDI	Class II	Active
Dio Biotite-H Implant Systems	SIP 4810T	FDA UDI	Class II	Unknown
DIO Implant Systems	IFI 4008M	FDA UDI	Class II	Unknown
DIOnavi. Guide (Anchor system)	GUIDE02 04 A03(a,b)	FDA UDI	Class I	Active

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